Regulatory Alert

A week after the US FDA issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning behind the agency's 50% efficacy threshold and where the agency stands on challenge trials and emergency use authorizations (EUAs). His comments came this week during a teleconference with the Alliance for a Stronger FDA. Learn More

The National Institutes of Health (NIH) has announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19. The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS. The network, dubbed the COVID-19 Prevention Trials Network (COVPN), is a functional unit of Operation Warp Speed, the federal partnership focused on speeding the development and delivery of COVID-19 diagnostics, therapeutics and vaccines. Learn More

This week, the US House Committee on Appropriations' Subcommittee which governs the FDA held a markup session for fiscal year 2021 appropriations. Of the total budget of $23.98 billion - a 2.3% increase from the prior fiscal year -- the bill allocates $3.212 billion for the FDA. This amount is an increase of $40.8 million over the prior fiscal year's approximate $3.2 billion budget. FDA funding will total $5.99 billion when user fee revenue is included. The FDA budget hike contained in the 2021 budget represents a smaller increase than the $91 million, or 3%, boost in appropriations the agency received in fiscal year 2020 compared with the prior fiscal year. Learn More

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) this week released their next five-year network strategy aimed at steering the regulators through a "time of rapid charge" for a two-month public consultation. The 46-page European medicines agencies network strategy to 2025 sets out six priorities for the regulatory network in the post-coronavirus era and follows the agencies' previous network strategy to 2020. Within the document, goals, challenges and interdependencies for each focus area are laid out. Once finalized, the goals and recommendations in the strategy will inform the work of EMA and the national competent authorities for the next five years. Learn More

A little-known but powerful law, 28 USC 1498, allows federal agencies to take control of industry owned patents using a tool known as government patent use. Essentially, government patent use would let HHS control both the manufacturing and distribution of remdesivir by simply paying compensation to Gilead for the use of its patents. HHS could license remdesivir manufacturing to multiple competing drug manufacturers, which would provide adequate supply while pushing prices down. Patients and payers would pay low prices for remdesivir, close to its manufacturing costs. Learn More

After a successful pilot program, the US FDA is fine-tuning a transition to all-digital submission of safety data from clinical trials of investigational drugs. The goal is to modernize the submission of regulatory data by shifting from use of multiple PDF documents into a digital submission format with structured data elements "that will allow us both to improve the data quality and also allow us to use new analytic tools," to make other novel uses of submission data, said Meredith Chuk, MD, Acting Associate Director for Safety with FDA's Office of Oncologic Diseases. Learn More

In an immediately effective guidance issued this week, the US FDA sets its expectations for the development and licensure of vaccines to prevent coronavirus disease (COVID-19), including considerations for manufacturing, nonclinical and clinical studies and post-licensure requirements. For a vaccine that would be widely deployed against COVID-19, the FDA says it expects sponsors to demonstrate that the vaccine is at least 50% effective in a placebo-controlled trial. At a Senate committee hearing this week, FDA Commissioner Stephen Hahn, MD, testified that the FDA would maintain its standards and independence in its decision to approve any vaccines for COVID-19. Learn More

Following a four-week public consultation, the EMA this week revised its guidance on methodological considerations for ongoing clinical trials amid the COVID-19 pandemic. The agency also says it will extend its decision to hold all upcoming committee and working party meetings virtually through September 2020. The agency adds that it will continue its practice of holding stakeholder events virtually or postponing them. The EMA first released its methodological guidance in late March, emphasizing the imperative to protect patient safety while charting a course to continue trials throughout the pandemic. Learn More

The U.S FDA has approved Zogenix's drug to treat seizures associated with a rare form of childhood epilepsy known as Dravet syndrome. The drug, branded as Fintepla, uses a low-dose liquid solution of fenfluramine, which was used in an obesity drug combination that was later withdrawn from the market due to evidence of heart valve damage. The approval contains a boxed warning, the FDA's harshest, flagging concerns about valvular heart disease and pulmonary arterial hypertension, and is available only through a restricted drug distribution program. Learn More

Following a rolling review that kicked off in late April, the EMA this week recommended conditionally authorizing Gilead Sciences' remdesivir to treat patients ages 12 and older with severe coronavirus disease (COVID-19) requiring supplemental oxygen. The EMA says it expects the European Commission to sign off on the conditional marketing authorization for remdesivir next week using a fast-track process, which will allow the drug to be marketed across the EU. As part of the conditional marketing authorization, the EMA says Gilead will have to submit final study reports for remdesivir by December 2020 and additional data on quality and final mortality data by August 2020. Learn More

As more candidate vaccines for the novel coronavirus are progressing to advanced clinical trials, international regulators are planning for international convergence on the nuts and bolts of what is needed to move to phase 3 trials of COVID-19 vaccines. This week, a group of regulators were convened under the umbrella of the International Council of Medicines Regulatory Authories (ICMRA) for a multinational discussion. In all, 100 regulators from more than 20 countries and the World Health Organization participated, with representation from 28 regulatory authorities at the virtual meeting. The meeting was co-organized by the US FDA and the EMA. Learn More

FDA Commissioner Stephen Hahn, MD, this week testified before the House Energy and Commerce Committee of the U.S. Congress on his agency's response to the coronavirus disease (COVID-19) pandemic. On the subject of user fee goals, Mr. Hahn stated "We are on target to meet our user fee goals for drugs this year by taking action on at least 90% of brand, generic and biosimilar drug applications, even during the pandemic." Despite Hahn's assurances, the FDA has acknowledged the possibility that it will miss some of its user fee program goals in its recent guidance on formal meetings and applications. Learn More

As part of an annual bilateral regulatory dialog, officials from the European Commission (EC), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) agreed on priorities for collaboration. The meeting represents a continuation of the collaboration between the EMA and FDA that began formally in 2003. Now, said EMA, the two agencies work together on a near-daily basis "with the aim to better align, and advance scientific and regulatory excellence worldwide." At the meeting, the regulators went over challenges each are facing in the race to develop vaccines for COVID-19 and make them available. The regulators, through ICMRA, are collaborating on other aspects of COVID-19 research. Learn More

A new guidance from the US FDA clarifies how manufacturers of drugs and biological products should address COVID-19 infection in their employees. Generally speaking, employees who are ill or infected with SARS-CoV-2, the novel coronavirus, must be excluded from drug manufacturing areas and not permitted to return until they have met home isolation criteria established by the US CDC. This guidance holds true for individuals who have a positive test for COVID-19, even if they do not have symptoms, and for individuals with COVID-19 symptoms, regardless of testing status. Evaluation of the employee's status should be made "in consultation with healthcare providers," according to the guidance, which is immediately effective for the duration of the public health emergency of the COVID-19 pandemic. Learn More

The number of European manufacturing noncompliance notices sent to Indian drugmakers fell to a new low last year, with just one good manufacturing practice (GMP) notice issued to an Indian company in 2019 compared to at least five annually over the previous four years, the European Medicines Agency (EMA) reported. It is unclear whether the low level of compliance failings in India is an anomaly or a sign that quality practices in the country are improving. An annual report published by the US FDA earlier this month indicates that the EEA data might be an anomaly. Learn More

The US FDA this week issued an immediately effective guidance offering statistical advice to clinical trial sponsors with the aim of maintaining trial integrity and mitigating the effects of coronavirus disease (COVID-19) public health emergency on clinical trials. The new document follows the agency's guidance on the conduct of clinical trials amid the pandemic, which has been updated several times to include additional questions and answers since being issued in March. While the agency's clinical trial conduct guidance has focused on ways to protect patients and mitigate the effects of COVID-19, the new statistical considerations guidance is meant to help sponsors with statistical considerations for changes to a trial. Learn More

The US FDA has warned Takeda over good manufacturing practice (GMP) violations observed during an inspection of its Hikari, Yamaguchi facility last November. Specifically, the warning letter cites the firm for three violations relating to its procedures for aseptic manufacturing and investigations into unexplained discrepancies and equipment malfunctions. The FDA says the company allowed manufacturing operations to resume without performing media fills as required in its procedures and shipped multiple batches of affected products to the US. Learn More

Hours after revoking its emergency use authorization (EUA) for hydroxychloroquine and chloroquine to treat coronavirus disease (COVID-19), the US FDA is now warning that the drugs could interact with Gilead Sciences' remdesivir, potentially reducing its antiviral activity. Remdesivir, also authorized under an EUA, is now the only drug with emergency authorization to treat COVID-19 in the US. The FDA also says it has updated its fact sheets for health care providers to include the potential drug interaction with hydroxychloroquine and chloroquine and to clarify dosing and administration recommendations. Learn More

The US FDA has announced that five companies have now voluntarily recalled extended-release metformin drugs because of elevated levels of N-nitrosodimethylamine (NDMA), a potential carcinogen. The five companies who were notified of the agency's testing results and who are recalling their extended-release (ER) product, and specific labeling and lots recalled, are: Apotex, Amneal, Marksans, Lupin and Teva, branded as Actavis. There are additional companies that manufacture ER metformin and supply a significant portion of the US market, whose products are not being recalled at this time," said the FDA. Learn More

BioPharma companies and officials at the US FDA are working with unprecedented speed and creativity during the ongoing coronavirus pandemic. But there's little reason to think the workload will abate, or the problems become easier, in the post-pandemic lives of sponsors and regulators, according to panelists who spoke during an FDA Town Hall at the Digital BIO 2020 meeting. Even amid the pandemic, not all of FDA's work is centered on COVID-19 vaccines and treatments. Learn More

Peter Marks, director of the US FDA's Center for Biologics Evaluation and Research (CBER) told a panel at BIO Digital he thinks global regulators will be aligned on the clinical endpoints and design features of Phase 2 and 3 clinical trials for vaccines to prevent coronavirus disease (COVID-19). Marks also emphasized that FDA is working closely with its colleagues around the world to expedite the development and availability of safe and effective vaccines to address the pandemic. Marks' statements followed a pre-recorded interview with Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, who called the virus his "worst nightmare" due to its rapid transmission and lethality. Learn More

In a new report, the US FDA's Office of Pharmaceutical Quality (OPQ) provides insights into the agency's quality oversight of drugs and biologics intended for the US market. Amongst the data shared in the report is that in FY2019, the FDA saw an 8.6% decrease in the number of drug manufacturing sites in its catalog, from 4,676 in FY2018 to 4,273, despite the addition of 382 new sites. Of the sites in FDA's catalog in FY2019, 1,793 (42%) were located in the US, 858 (20%) in the EU, 505 (12%) in India and 379 (8%) in China. The FDA says its investigators performed 1,258 drug quality surveillance inspections in FY2019, a drop from the 1,346 conducted in FY2018. Learn More

The EMA this week said it has received a conditional marketing authorization application for Gilead Sciences' remdesivir to treat coronavirus disease (COVID-19) that could receive an opinion in a matter of weeks. If the application is recommended for authorization, the EMA says it will work with the European Commission to fast-track the process of granting a marketing authorization for the drug. The EMA says its scientific committees and working parties have already assessed quality and manufacturing data as well as preliminary clinical and supporting data as part of the rolling review. Learn More

The World Health Organization (WHO) has prequalified Celltrion's biosimilar version of rituximab, the second product achieving that status under a biosimilar prequalification pilot begun by the agency in 2018. The prequalification pilot program for rituximab and another monoclonal antibody, trastuzumab, is meant to smooth the path to greater adoption of these effective therapies in nations with fewer resources. A biosimilar to trastuzumab, the other biologic medication included in WHO's pilot program, was prequalified in December 2019. Both medications are included in the agency's Essential Medicines List. Learn More

In a newly issued compliance program, the US FDA explains its approach to inspections of Center for Drug Evaluation and Research (CDER)- and Center for Devices and Radiological Health (CDRH)-led combination products. The 46-page document lays out FDA's intended implementation of the compliance program; inspectional operations and reporting considerations; sampling and analytical testing expectations; regulatory and administrative strategy; and an explanation of center responsibilities. The FDA says the compliance program focuses mainly on single-entity and co-packaged combination products that feature drug and device or biological product and device constituent parts. Learn More

A government watchdog blasted the FDA for fumbling its oversight of the safety of the U.S. drug supply chain, suggesting the agency is not adequately conducting drug safety inspections overseas. The criticisms came in a hearing this week before the Senate Finance Committee, at which a top official for the Government Accountability Office outlined a number of surprising deficiencies in the FDA's surveillance of foreign drug manufacturing. It highlighted, in particular, the agency's longstanding practice of alerting drug makers in advance that it plans to conduct an inspection. U.S.-based drug makers do not get a similar heads-up. Learn More

The FDA has announced that it has asked five pharmaceutical firms to voluntarily recall products containing extended-release formulations of metformin hydrochloride, a drug frequently prescribed to patients with type 2 diabetes to manage blood glucose levels. The recall stems from a recent series of tests that revealed unacceptably high levels of N-nitrosodimethylamine, a probable human carcinogen, in several lots of metformin extended-release products. Of those five, the only recall notice currently listed on the FDA's website is for all lots of metformin 500-mg tablets marketed by Apotex. However, the agency says it will post additional recall notices as they are published. Learn More

The US FDA will look to permanently implement some of the processes and policies adopted in its response to the coronavirus disease (COVID-19) pandemic, FDA Commissioner Stephen Hahn said during a virtual briefing hosted by the Alliance for a Stronger FDA. Hahn's statements during the briefing closely mirrored statements he made in a pre-recorded video FDA uploaded to YouTube. Hahn added that many of the changes the agency will implement "represent an acceleration of where we were headed before," and include support for decentralized clinical trials, greater use of telemedicine technology in clinical trials and work related to laboratory-developed tests. Learn More

Nearly 40 years after its creation, the US FDA is looking to modernize its Orange Book, which lists patent, exclusivity and therapeutic equivalence information for approved drugs, as part of its effort to increase drug competition. Specifically, FDA is seeking input on how the Orange Book is used and by whom, and on the types of patents that should  be submitted for listing in the book, such as those covering the device constituent of a drug-device combination product or a patent for a risk evaluation and mitigation strategy (REMS) for an approved drug. The agency also released a draft guidance featuring 19 questions and answers covering general questions related to the Orange Book. Learn More

The EMA and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP). Specifically, the guidance lays out four questions and answers pertaining to GMP flexibilities and three questions and answers on GDP flexibilities, as well as a new section on the suspension of on-site inspections of plasma collection centers. Learn More

A South Korean drug manufacturing firm was cited by the US Food and Drug Administration for having insufficiently trained personnel and for insufficient monitoring of aseptic processing areas. The deficiencies were detected in an October 2019 FDA inspection of Samchundang Pharm's Hwaseong facility. The agency found that Samchundang failed to establish the suitability of the sterility test method it used for final release of its drug products and also didn't determine whether the in-process bioburden test it used was suitable. "Suitability testing must be performed for each drug product to ensure the sterility test method is valid. Suitability testing establishes that contamination, if present, will be detected," noted the FDA. Learn More

The US FDA has launched a two-month public consultation on an International Council for Harmonization (ICH) guideline establishing new permitted daily exposures (PDEs) for three residual solvents. Specifically, the ICH Q3C(R8) guideline is a product of the maintenance procedure for updating ICH's guideline for residual solvents as new toxicological data for become available. The eighth revision to the guideline adds PDEs for three new solvents, 2-methyltetrahydrofuran, cyclopentyl methyl ether and tert-butyl alcohol. Specific PDEs for these residual solvents, FDA said, "were developed according to the methods for establishing exposure limits" found in the Q3C guideline. Learn More

The US FDA and FTC have warned Seattle-based firm North Coast Biologics for marketing an unapproved vaccine for SARS-CoV-2, the virus that causes COVID-19, on Facebook and LinkedIn in March and April. The warning letter comes nearly a month after Washington Attorney General Bob Ferguson sent a cease and desist letter to North Coast Biologics President Johnny Stine ordering him to "immediately stop making misrepresentations" about the vaccine. The FDA says North Coast Biologics must reply to the warning letter within 48 hours describing the steps taken to address the violations cited in the letter. "Failure to immediately correct the violations cite in this letter may result in legal action, including, without limitation, seizure and injunction." Learn More

Cases of neuropsychiatric disorders in Spanish patients taking hydroxychloroquine for the treatment of COVID-19 have triggered a Europe-level review of the safety of the treatment. Concerns about the risks posed by administering hydroxychloroquine to COVID-19 patients have so far primarily focused on the link between the drug and cardiac arrhythmia. However, the history of use of hydroxychloroquine in the treatment of conditions including lupus and malaria shows the drug is associated with other adverse events, some of which are now being seen in COVID-19 patients. Learn More

The European Medicines Agency (EMA) has announced it is extending its decision to hold all upcoming meetings virtually through August 2020 as a safety measure amid the ongoing coronavirus disease (COVID-19) pandemic. The EMA first made the shift to virtual-only meetings because of COVID-19 in March and extended the policy in April to continue through the end of May. Since mid-March, most EMA staff have worked remotely as well.  While many countries in Europe have taken the first steps to reopen their economies in recent weeks as new cases of COVID-19 have fallen, much of business as usual remains on hold. Learn More

The US FDA last month issued a warning letter to contract testing laboratory International Trading Pharmaceutical Laboratories (ITPL) over significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). During a two-week inspection in October 2019, the FDA found that ITPL's Quality Unit had not acted on findings of an out-of-specification (OOS) investigation; chromatographic injections of samples were not included in the investigation or reviewed. Also, the client was not informed of OOS findings. Data from several samples tested with chromatographic injections were either omitted from the analyst's notebook, or not included in the OOS investigation. Learn More

The US FDA has updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address how and when sponsors and application holders should report serious adverse events (SAE). The latest update to the guidance comes just days after the FDA added new questions and answers to the document addressing the use of alternate laboratory or imaging centers, video conferencing and postmarketing studies. The updated guidance includes two new questions and answers on serious adverse event reporting requirements in different circumstances. Learn More

The European Medicines Agency (EMA) has announced it is waiving fees for on-site good manufacturing practice (GMP) inspections of drugmakers and blood establishments that have undergone remote inspections during the coronavirus disease (COVID-19) pandemic under certain circumstances. Specifically, EMA says it will fully waive fees for sites that undergo remote inspections where GMP compliance cannot be confirmed and the inspection must be rescheduled "due to the limitations of a distant assessment." The policy entered into force on May 12th and will remain in place "during the period where access to sites for inspections were restricted due to COVID-19." Learn More

A vaccine against SARS-CoV-2, the novel coronavirus scourging the globe, could be approved in the European Union in about a year, Marco Cavaleri, the European Medicines Agency's top official overseeing anti-infectives and vaccines, said this week. Cavaleri cautioned that this is an optimistic view but said the ambition is to have a vaccine approved next Spring and that he is skeptical of claims that a vaccine could be ready by September. Cavaleri also said that EMA expects all vaccines to prevent coronavirus disease (COVID-19) will be studied in large Phase 3 trials before approval and noted that EMA would be open to reviewing data from challenge studies, where volunteers are intentionally infected with the virus, if such studies were found to be ethical. Learn More

The US FDA this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address new questions, including the use of alternate laboratory or imaging centers, video conferencing and post-marketing requirements. The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take when considering administering investigational products at home instead of at clinical trial sites. Learn More

After halting most foreign and domestic inspections in March due to the COVID-19 outbreak, the US FDA this week said it is working with the CDC on a phased plan for resuming on-site surveillance inspections. The FDA had previously limited travel and inspections relying instead  on "alternative inspection tools and approaches" as it postponed most routine surveillance inspections. "We expect this to be a phased approach driven by scientific data. Our priority and commitment are to first protect the health and well-being of not only our own highly-skilled workforce and state contract inspectors, but also the health of workers in the important industries we regulate," says FDA Commissioner Stephen Hahn. Learn More

The EMA this week recommended expanding compassionate use programs for Gileads' investigational drug remdesivir to treat COVID-19 patients who are not on mechanical ventilation and to allow for a shorter treatment duration based on the results of two recent clinical studies. In early April, the EMA released its initial recommendations for providing remdesivir through compassionate use programs for patients who are ineligible for clinical trials. Now, the EMA says that compassionate use programs for remdesivir should be expanded to include hospitalized patients who need supplemental oxygen, non-invasive high-flow oxygen devices or ECMO machines. Learn More

The US FDA has granted the first emergency use authorization (EUA) allowing for at-home saliva sample collection for a coronavirus disease (COVID-19) diagnostic and opened the door to wider at-home sample collection. The EUA allows Rutgers Clinical Genomics Laboratory to use its TaqPath SARS-CoV-2 Assay, which was previously covered under the umbrella EUA for laboratory developed tests (LDT) for COVID-19, to test home collected saliva samples using the Spectrum Solutions LLC SDNA-1000 saliva collection device. While the test is authorized for at-home sample collection, a prescription is required, and the EUA limits testing to be performed only at Rutgers' laboratory. Learn More

The US FDA says it has warned 42 companies for marketing fraudulent, unproven products to treat, prevent or diagnose coronavirus disease (COVID-19). The products include some familiar "bogus" remedies, including "miracle mineral solution," a chlorine bleach mixture that FDA has warned against for the last decade, and colloidal silver. Other products caught up in the enforcement sweep include unapproved drugs, herbal remedies, tinctures and cannabidiol (CBD). The 42 warning letters appear to be just the tip of the iceberg. The FDA says it has found hundreds of fraudulent products, including drugs, test kits and personal protective equipment (PPE) as part of its "Operation Quack Hack" in recent weeks. Learn More

The U.S. FDA has decided to extend the approval timeline for Bristol Myer Squibb's experimental blood cancer therapy that was acquired as part of the $74 billion buyout of Celgene. The company said it had submitted additional information on the therapy known as liso-cel, which was considered a major amendment to the marketing application by the agency, which would now announce its decision by November 16th versus its earlier deadline of August 17th. The extended review for liso-cel does not alter the likelihood of approval, but narrows the window for the December 31st CVR deadline for the therapy. Learn More

The US FDA's Center for Drug Evaluation and Research (CDER) has issued a new manual of policies and procedures explaining its internal process for identifying, evaluating and resolving newly identified safety signals for marketed drugs. This new manual is meant to provide a "high level" overview of how and when communication related to newly identified safety issues is transmitted between different offices and disciplines within CDER. The manual applies to safety signals related to approved drugs and biologics, marketed yet unapproved drugs, over-the-counter monograph products, compounded drugs and medical gases. Learn More

After initially allowing commercial manufacturers and laboratories to market self-validated antibody tests for COVID-19, the US FDA says that commercial manufacturers must now submit an EUA with validation data to continue marketing the tests. Under its original policy, the FDA said it would not object to the development and use of serological tests without FDA review or authorization so long as the tests were validated, and the agency had been notified that the company planned to market the tests. More than 100 antibody tests were marketed under the initial policy. The policy change comes after reports emerged questioning the accuracy of some of the tests on the market. Learn More

The U.S. FDA approved Gilead's remdesivir under Emergency Use Authorization as a treatment for COVID-19 following reports the drug met its primary endpoint in a U.S. National Institute of Allergy and Infectious Diseases (NIAID) clinical trial. The EAU came barely 48 hours after results from the NIAID trial that showed COVID-19 patients receiving remdesivir had a 31% faster time to recovery than the placebo group. As BioSpace reported this week, patients who received remdesivir recovered about four days faster than those on placebo, a median of 11 days versus 15 days, respectively. Survival benefit was not statistically significant, but the results do suggest a survival benefit. Learn More

In a newly posted guideline that takes effect today, the European Medicines Agency (EMA) explains EU-wide follow-up procedures for pharmacovigilance inspections. The 15-page document supersedes an earlier version for 2014 and includes new sections and a more detailed timeframe for post-inspection actions. Following inspections, EMA says that lead inspectors should propose deadlines for responses to inspection findings, which should routinely be set at 30 working days from receipt of the inspection report. The guideline includes new sections discussing how to manage unacceptable responses to inspection findings, sharing of inspection reports, periodic progress reports and post-inspection meetings. Learn More

The US FDA this week gave advice to generic drugmakers on handling disruptions to bioequivalence studies needed to support abbreviated new drug application (ANDA) approval as a result of the coronavirus disease (COVID-19) pandemic. For bioequivalence studies, the FDA says that "Challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference listed drug product, or other considerations if site personnel or study subjects become infected with COVID-19." The FDA also points out that interruptions to bioequivalence studies could require protocol changes and disrupt the collection of information from studies. Learn More

Members of the International Coalition of Medicines Regulatory Authorities (ICMRA) this week pledged to work together to speed the development and approval of medical products used in the fight against coronavirus disease (COVID-19). The statement follows several meetings organized by ICMRA aimed at developing a consensus among its members on data requirements for Phase 1 clinical trials for COVID-19 vaccines, developing therapeutics for the disease and using real-world evidence and observational studies to complement data from clinical trials. Learn More

Millions of Americans own an Apple Watch, which commands roughly a 50 percent share of the smartwatch market. Among its many features, the Apple Watch can take your pulse. It also contains hardware to measure your blood-oxygen levels, and it has been doing so since the watch was released-but the hardware is not operable by the watch's wearer, who thus cannot obtain the results. Under current FDA regulation, the function is disabled. Learn More

The US FDA has warned against the use of malaria drugs hydroxychloroquine and chloroquine to treat coronavirus disease (COVID-19) outside hospitals or clinical trials due to serious heart risks. The FDA says it is "aware of reports of serious heart rhythm problems," including deaths in COVID-19 patients treated with the drugs, either alone or in combination with other QT-prolonging drugs such as azithromycin, and warns that patients with heart and kidney disease may be at higher risk. The warning comes after the FDA took the unusual step of granting an emergency use authorization (EUA) allowing the drugs to be used to treat hospitalized COVID-19 patients who are unable to participate in clinical trials. Learn More

The MHRA has relaxed its interpretation of good manufacturing practices (GMPs) in light of challenges created by the COVID-19 pandemic. MHRA's more flexible approach to GMPs is intended to achieve two goals. Firstly, MHRA hopes to free up quality system capacity to help companies "focus on ensuring continuity of supply using quality risk management principles." Secondly, the agency intends to "address specific challenges created by international travel restrictions." Those goals led MHRA to take a new approach to several aspects of GMPs. Under the relaxed rules, manufacturers can limit retesting to identification "where supplier history, material criticality, and the finished product quality control strategy permits." Learn More

Updated April 22nd, 2020 with new information on vaccines from Moderna, University of Oxford, Inovio, BioNTech, Sinovac and Novavax; the addition of new candidates from University of Waterloo and University of Georgia; and updates to preclinical data for Vaxar and Takis Biotech. Currently, there are no FDA-approved therapies or vaccines for SARS-CoV-2, the virus that causes COVID-19. Learn More

The US FDA this week granted an emergency use authorization (EUA) to LabCorp allowing it to test self-collected nasal swab samples from patients for coronavirus disease (COVID-19) with its COVID-19 RT-PCR Test. The FDA first granted LabCorp an EUA for the test on March 16th, but limited sample collection to upper and lower respiratory specimens collected by healthcare providers. While the EUA permits at-home sample collection, the testing itself must be conducted at LabCorp's Center for Esoteric Testing and other Clinical Laboratory Improvement Amendments (CLIA) certified high complexity laboratories designed by the company. Learn More

The US FDA has revised its manual of policies and procedures (MAPP) to clarify when certain abbreviated new drug application (ANDA) amendments and supplements should be reviewed by the Office of Generic Drugs' (OGD) Division of Filing Review (DFR). The DFR is tasked with reviewing all original ANDAs for completeness and deciding to receive or refuse receipt of the application. In some instances, DFR also reviews amendments to pending ANDAs and prior approval supplements (PASs) to approved ANDAs "to identify deficiencies that, if addressed before assessment by the review disciplines, will streamline the assessment process." Learn More

The NIH has announced a new initiative to accelerate the development of treatments and vaccines for COVID-19 involving the US FDA and other US health agencies, the EMA and 16 drugmakers. The goal of the Accelerating COVID-19 Therapeutic Interventions and Vaccines partnership will be to develop a coordinated research strategy to prioritize drug and vaccine candidates and coordinate clinical trials and regulatory processes. The announcement comes just days after a report called the search for treatments for the disease "disorganized and scattershot" and revealed that NIH Director Francis Collins had been working for the past month to piece together the public-private partnership. Learn More

The MHRA has published a guidance on how people can approve paper good practice documents while working from home. In its public response, the MHRA notes that many companies already have systems in place that support the remote electronic signing of documents. Such companies should continue to use those systems. If a company lacks such a system, MHRA is open to them establishing alternative workflows that use the technologies they have available. Whether workers have access to printers, scanners, secure mail, smartphones or other technology will dictate the exact nature of the alternative workflows. Learn More

In a perspective published in the New England Journal of Medicine this week, Harvard professors Benjamin Rome and Jerry Avorn call on the US FDA to maintain its drug approval standards amid the coronavirus disease (COVID-19) outbreak. Rome and Avorn express concern about the agency's issuance of an emergency use authorization (EUA) for chloroquine and hydroxychloroquine following President Donald Trump's promotion of the drugs as potential game changers, despite limited evidence to support the drugs' efficacy. The authors note that this is only the second time the FDA has issued an EUA for a drug during a public health emergency. Learn More

After loosening restrictions on antibody tests roughly a month ago, the US FDA has decided government scientists will review data on lab tests that claim they can detect if someone has antibodies to Covid-19. According to Scott Becker, CEO of the Association of Public Health Laboratories, who was on a call with FDA officials this week, the move comes in response to "crappy" tests flooding the market. According to Mr. Becker, FDA Commissioner Stephen Hahn told him and members of his association that the National Cancer Institute (NCI) would start reviewing tests that are on the market to see if they obtain correct results. Learn More

The U.S. FDA has granted emergency use authorization (EUA) to Rutgers' RUCDR Infinite Biologics for its test that uses saliva. The test method was developed by RUCDR with Spectrum Solutions and Accurate Diagnostic Labs (ADL). The Trump administration's COVID-19 testing task force has already contacted RUCDR about how they can help expand testing and allow labs to leverage the technology. Biopharma executives for companies involved in COVID-19 testing also contacted the group. Learn More

The US FDA has issued a second emergency use authorization (EUA) to help decontaminate N95 or N95-equivalent respirator masks so they can be reused by health care workers in hospitals. The FDA said this EUA, issued to Steris Corporation for a system that uses vaporized hydrogen peroxide, will support the decontamination of about 750,000 N95 respirators per day in the US. The system works by allowing the hydrogen peroxide vapor to fill the sterilization chamber, penetrate the device and sterilize exposed surfaces, FDA said. The company's system is capable of processing 10 respirators at one time through a process that takes about 28 minutes, and each respirator can be processed up to 10 times for single-user reuse. Learn More

The MHRA has provided guidance to manufacturers and laboratories that need outside engineers to maintain or calibrate their equipment during the COVID-19 pandemic. Typically, manufacturers and laboratories ask external service personnel and engineering support staff to visit their facilities to perform maintenance and calibration work. These support staff help keep the equipment functioning and the facilities in compliance with good regulatory practices. Recognizing that, MHRA has provided a slate of options for companies that need their equipment maintained or calibrated. Learn More

The European Commission this week reassured the generic drug association Medicines for Europe that member and nonmember companies can work together to battle shortages of critical hospital drugs to treat COVID-19 patients. The commission explains how generic firms may need to coordinate on stock management and distribution "so that not all undertakings focus on one or a few medicines, while others remain in under-production. Such coordination would be contrary to antitrust rules in normal circumstances. But in the context of a pandemic like the coronavirus outbreak, such coordination can, with appropriate safeguards, bring important benefits to citizens." Learn More

China's Center for Drug Evaluation (CDE) has shared a guidance for companies developing biosimilar copies of AbbVie's blockbuster Humira. The draft guidance covers how to perform pharmacokinetic comparisons in healthy subjects and assess clinical effectiveness in patients. To support the development of such products, CDE has created clinical trial guidance focused on the assessment of Humira biosimilars. The guidance refers to general guidance on the clinical study of biosimilars, but also features points specific to Humira and the patients who take the drug. The CDE is accepting feedback on the draft throughout April. Learn More

The length of review of new drug applications (NDAs) by the US FDA divisions is generally contingent on four features of the application, according to the Government Accountability Office's (GAO) analysis of 637 original NDAs submitted from fiscal years 2014 through 2018.

Overall, GAO found that the four key features are:

1. Whether the NDA qualifies for a priority review, which is four months less than for an otherwise standard, 10-month review.

2. Whether the NDA is for a new molecular entity (not previously marketed or approved in the US), which adds two months to a review.

3. Whether the applicant submits a major amendment while the NDA is under review, which can extend a review by three months.

4. Whether the NDA qualifies for one of FDA's expedited pathways (Fast Track, Breakthrough Therapy, Accelerated Approval) that can speed reviews of certain drugs for rare or serious conditions.

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A new report from Booz Allen Hamilton commissioned by the US FDA recommends refinements to the agency's workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II) user fee programs. The 25-page report makes five main recommendations for FDA to improve its capacity planning adjustment methodology but finds that overall FDA's methodology and current implementation of its resource capacity planning "align conceptually" with the agency's objectives. The FDA is now soliciting public comments on the report and says it will develop a "new robust methodology" to use going forward based on the recommendations and the comments it receives. Learn More

In a move that could help the US better understand who has already had COVID-19, the US FDA this week provided the first Emergency Use Authorization (EUA) for a serology test to North Carolina-based Cellex Inc. The test can detect SARS-CoV-2 antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG) that are generated as part of the human immune response to the virus. Although FDA recommends that results from serology testing should not be used as the sole basis to diagnose or exclude a coronavirus infection, the test can help detect how many people have had SARS-CoV-2, even if they did not show symptoms. Learn More

The US FDA has requested that all manufacturers of drugs containing ranitidine remove all prescription and over-the-counter versions from the market because the carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in samples stored at higher temperatures. This comes amid new FDA testing and evaluation prompted by information from third-party laboratories "confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers," the FDA said. Learn More

Following an inspection last August and September, the US FDA sent a warning letter to Pfizer's injectable product manufacturing site in Visakhapatnam, India. The letter, dated March 25th and released this week, explains how the site did not adequately investigate root causes and implement corrective and preventive action (CAPA) to address deficiencies with its sterility testing. The FDA also notes microbial contamination and how the site "did not adequately investigate serious deficiencies in microbiology laboratory conditions and practices." In addition, the site invalidated microbial results without adequate scientific justification. Learn More

Opening the door to the wider use of unapproved but potential COVID-19 treatments, the US FDA has issued an emergency use authorization (EUA) to allow BARDA to distribute donated hydroxychloroquine sulfate and chloroquine phosphate products to doctors, who can decide whether to prescribe them to hospitalized teen and adult patients with COVID-19 when a clinical trial is not available or feasible. This is FDA's first EUA for a therapeutic product to potentially treat COVID-19. The donations to be distributed include 30 million doses of hydroxychloroquine sulfate from Sandoz and one million doses of chloroquine phosphate from Bayer. Learn More

The US FDA has published a new guidance on how manufacturers should notify the FDA of permanent halts or interruptions to manufacturing certain products that are likely to lead to a meaningful disruption in supply. So far, only one firm is reporting a shortage of one human drug. The FDA previously declined to name the firm or the drug, citing confidential commercial information. FDA staff also have been proactively reaching out to manufacturers to identify potential disruptions or shortages of drugs. And although the shutdown of certain areas in China heightened concerns because the US relies heavily on products and active ingredients manufactured there, Chinese manufacturers seem to be coming back online now. Learn More

The US FDA this week officially ended a fledgling pilot program that was part of an effort to provide more transparency on the drug approval process. The agency said it's working on a new approach to disclosing study reports. Last June, the agency was already pushing away from the clinical study report (CSR) pilot because of lackluster participation, Janssen was the only sponsor that agreed to participate,  and said it would focus its efforts to better communicate the basis for drug approvals on the development of new integrated review documents. Janet Woodcock, director of CDER, said in a statement that the FDA has learned some useful information from the CSR pilot. Learn More

To increase the availability of personal protective equipment (PPE) and other medical devices amid the coronavirus disease (COVID-19) pandemic, the US FDA this week eased import requirements for certain products. Typically, companies importing FDA-regulated products are required to submit entry information to the agency for the products. However, to ease burdens on importers and speed up the entry process for PPE and certain devices intended for emergency use or covered by an enforcement discretion policy, FDA is reducing the amount of information that needs to be submitted. Learn More

As Gilead begins to streamline the process for COVID-19 patients to receive its experimental antiviral remdesivir on a wider basis, the company also raised some eyebrows this week by obtaining an orphan drug designation for the potential COVID-19 treatment. Orphan designations are meant to help companies developing treatments for limited populations and they provide incentives like tax credits for research and seven years of exclusivity for the sponsors of such drugs. Although the number of COVID-19 cases is currently below 200,000, some have begun to criticize this designation as just the latest in a series of orphan drug abuses. Learn More

The law that opened up the approval pathway for biosimilars, known as the Biologics Price Competition and Innovation Act (BPCIA), turned 10 years old this week and nearly 100 drugs officially became biologics under what's known as the "deemed to be a license" provision of the BPCIA. As anticipated, the shift for these nearly 100 products will mean insulin and treatments for respiratory distress syndrome, fertility conditions, Cushing's syndrome, deep vein thrombosis, Gaucher disease and others will be marketed under biologics license applications (BLAs) and see biosimilar competition moving forward. Earlier this month, the FDA finalized guidance on what this transition means for sponsors of these products. Learn More

As the US FDA re-gears to respond to the coronavirus disease (COVID-19) pandemic, the agency's Center for Biologics Evaluation and Research (CBER) says it will "significantly scale back" lot release activities. In a letter to biological product manufacturers, CBER's Office of Compliance and Biologics Quality (OCBQ) advises that it will no longer accept biological product samples or lot release protocols in physical form (paper or CD-ROM) at the agency's headquarters in Silver Spring, MD until further notice. Despite the pause in other lot release activities, CBER says it will continue to prepare reagents for the 2020/2021 influenza season. Learn More

The Health Products Regulatory Authority (HPRA) of Ireland has joined the US FDA in canceling what it terms "routine compliance inspections". These initial cancelations are scheduled to last through March 29th. However, with the rate of new daily cases in Ireland still increasing, it is being speculated that the cancellations may continue well beyond this date. No word as of this writing what, if any, changes might be coming to the site inspection plans of other European regulators such as the United Kingdom's MHRA. Learn More

The US FDA has formally announced that it has temporarily postponed all domestic routine surveillance facility inspections. The decision, which FDA said is for "the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors". FDA Commissioner Stephen Hahn said in a statement: "I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate." Learn More

The US FDA this week released a warning letter sent to a Goa, India-based manufacturing site of pharmaceutical company Cipla. Following a more than week-long inspection last September, the FDA uncovered cross-contamination of products, noting, "Your testing confirmed the presence of active ingredients from a previous product in batches of the next product." And the firm's "lack of a clear root cause casts doubt on whether you have fully resolved a serious cross-contamination problem," the FDA said. The agency acknowledged that the site has suspended production in several sterile units. Learn More

The US FDA unleashed the private sector over the weekend, granting Emergency Use Authorizations (EUA) to Thermo Fisher Scientific in vitro diagnostics. The company says it currently has 1.5 million tests available to ship under its EUA and expects to quickly ramp up to reach 2 million tests per week. Two other lab testing companies - Quest Diagnostics and LabCorp - are also pursuing EUAs and ramping up testing. Quest said on Saturday that it expects to have capacity to perform approximately 10,000 tests a day by the end of next week and approximately 20,000 tests a day by the end of the month. Learn More

The U.S. FDA has granted Roche's Cobas SARS-CoV-2 Test Emergency Use Authorization. Hospitals and laboratories will be able to run the test on Roche's fully automated Cobas 6800 and Cobas 8800 Systems, which are already in wide use in the U.S. and internationally. This test is for the coronavirus that causes COVID-19, which was classified a pandemic by the World Health Organization. The new test can give results in about three-and-a-half hours and can run up to 4,128 test results per day. The Emergency Use Authorization allows the test to be conducted in the U.S. and in countries that accept the CE mark showing they conform to European standards. Learn More

The US FDA this week offered advice to healthcare providers to conserve their supply of personal protective equipment (PPE), such as surgical masks and gowns, as fears of supply constraints mount amid the global coronavirus disease (COVID-19) pandemic. FDA's recommendations are tiered based on the situation within individual healthcare organizations and the level of supply of PPE available to them. The FDA notes that these strategies do not apply to N95 respirators but do apply broadly to patient care beyond those being treated for COVID-19. Learn More

The World Health Organization this week declared the ongoing coronavirus (COVID-19) outbreak to be a global pandemic, marking the first time since the 2009 H1N1 influenza outbreak the agency has used the designation. Hours before the announcement, the European Medicines Agency (EMA) said it will be holding all its committee and working party meetings virtually through April in response to the ongoing coronavirus (COVID-19) outbreak. EMA also said it will postpone or virtually host all meetings and events with stakeholders originally scheduled to take place in March and April. Learn More

As a precaution amid the global coronavirus outbreak, the US FDA this week canceled all foreign travel by agency officials and said it is limiting domestic travel to "mission critical only" through April. FDA Commissioner Stephen Hahn also said the agency will postpone most foreign inspections, though some "will still be considered on a case-by-case basis." Last month, the FDA stopped conducting inspections in China while the outbreak was mostly contained within the country. For her part, CDER Director Janet Woodcock said that CDER-organized meetings, conferences and workshops will be postponed or canceled through April. Learn More

In a draft guidance issued this week, the US FDA proposed a new, broader approach to conducting safety evaluations for new drugs to treat type 2 diabetes that looks beyond assessing cardiovascular (CV) risk. The new four-page draft guidance replaces the agency's 2008 guidance on evaluating cardiovascular risk in type 2 diabetes drugs, as well as the agency's 2008 draft guidance on developing drugs to treat or prevent diabetes. Unlike the agency's previous guidance, the new draft guidance does not recommend sponsors "uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes." Learn More

Since 1971, Annex 1 of the EU's good manufacturing practice (GMP) guide has helped with the manufacture of sterile medicinal products, but now the European Commission, European Medicines Agency, PIC/S and WHO are launching a second consultation on fully revising the annex and introducing the principles of Quality Risk Management (QRM). A first consultation on the guideline was previously conducted from December 2017 to March 2018 and about 140 companies and/or organizations commented. The joint PIC/S-EMA drafting group (with WHO participation) said they processed more than 6200 lines of comments. Learn More

The UK government has detailed what it hopes to get out of its Brexit trade deal talks with the EU. United Kingdom officials are seeking multiple provisions intended to facilitate trade in medicinal products, for example by proposing for each side to recognize GMP certificates issued by the other. Unlike the European Commission, which provided scant details of its thinking about medicines and medical devices in its negotiating guidelines, the UK government detailed multiple specific objectives related to the industry in a document outlining its approach to the talks. The UK government wants an annex on medicinal products designed to facilitate cross-border trade. Learn More

In preparation for certain NDAs to be converted to BLAs on March 23rd, the US FDA this week finalized a questions and answers (Q&A) guidance on the transition. The Q&A has been updated to reflect the recent change from the latest appropriations bill, enacted in December, which further amended the definition of "biological product" to include chemically synthesized polypeptides. The change in the definition effectively means that three additional products will make the transition (in addition to the almost 100 others listed last year). But other companies, like Teva, have requested that FDA include their products in the transition. Learn More

The US FDA's Center for Biologics Evaluation and Research (CBER) is looking for ways to facilitate the development of more products intended to treat individual or small groups of patients, including cell and gene therapies, antisense oligonucleotides and phage therapies. At a workshop at the FDA's headquarters in Silver Spring, MD this week, CBER Director Peter Marks addressed some of the barriers to developing individualized therapies such as "customized products" with a single indication and a mode of action that are tailored to individual patients, or "created products" that could target different indications via different modes of action. Learn More

The US FDA this week released a batch of 43 new and revised draft product-specific guidance's to support the development of generic drugs. The guidance's, when finalized, are intended to promote generic competition by clarifying FDA's expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, FDA has issued a total of 1,832 product-specific guidance's. This latest batch features 33 new and 10 revised draft product-specific guidance's and comes more than three months after the agency's last batch. Among the revised draft guidance's are five that provide recommendations for complex generics. Learn More

At its recent meeting the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended one new and one generic medicine for authorization and launched a review of medicines supported by an Indian contract research organization (CRO) citing data integrity concerns. Specifically, CHMP recommended the authorization of Shionogi's Fetroja (cefiderocol) to treat Gram-negative bacterial infections and Accord Healthcare's generic version of the antibiotic tigecycline. The recommendation for Fetroja comes after the US FDA approved the drug to treat certain complicated urinary tract infections caused by Gram-negative bacteria last November. Learn More

Acacia Pharma announced this week that the US FDA has approved BARHEMSYS® (amisulpride injection) for the prevention and treatment of PONV in adult patients. The Company owns global rights to BARHEMSYS and intends to directly commercialize the product in the US through its own sales channel, having built critical sales, marketing, medical, and operational infrastructure and capabilities over the past two years. The Company plans to launch BARHEMSYS in 2H 2020. Learn More

The US FDA has identified 20 drugs that are made in or produced solely from active pharmaceutical ingredients (APIs) sourced from China. In a statement, FDA spokesperson Stephanie Caccomo said the agency has been in contact with the companies that make the 20 products and that "none of these firms has reported any shortage to date." Caccomo also said that FDA has been in contact with more than 180 manufacturers to remind them of their responsibility to notify the agency of anticipated supply disruptions and ask that they review their supply chains for API and other components sourced from China. Learn More

The US FDA this week released three warning letters sent earlier this month. One to Yibin Lihao noted that the company told FDA inspectors that they had not produced crude heparin "for months," but inspectors found "two batches of crude heparin manufactured just a few days before the FDA inspection." The FDA's warning letter to India's JHS Svendgaard Hygiene Products notes how the firm lacked adequate testing for incoming API and thus relied on its suppliers' certificates of analyses (COA). While for India CMO Essnd, the FDA said the firm released drug product without adequate testing, including identity and strength testing of the active ingredient. Learn More

The US FDA this week unveiled the first version of its searchable online database of biological product information, known as the Purple Book. Building off the previous PDF lists of biological products, the database now allows for easier searches and includes information on product names, the type of biologics license application (BLA) that was submitted, strength of the biologic, dosage form, product presentation, license status, BLA number and approval date. Biopharma companies previously requested that FDA include exclusivity information in the Purple Book, similar to what's offered in the Orange Book, and FDA says that a later iteration of the database will include such dates. Learn More

A month before the long-anticipated transition of applications for certain biological products to be deemed to be licensed as biologics, the US FDA has issued a final rule amending its definition of "biological product." Effectively, on March 23rd, 2020, some 100 products approved under new drug applications (NDAs) will transition to biologics license applications (BLAs). Under the rule, the FDA is amending its definition of "biological product" in line with the statutory definition set by the BPCIA. As such, the FDA now interprets the term "protein" to mean "any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size." Learn More

The U.S. FDA and the Federal Trade Commission today signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space. Learn More

The US FDA this week issued a new draft guidance consolidating its recommendations on nonclinical safety evaluations for immunotoxicity and withdrew an earlier 2002 guidance on the topic. The FDA says the guidance addresses issues related to evaluating immunotoxicity including immune suppression, modulation and stimulation and provides recommendations for carcinogenicity assessments, dermal sensitization, adjuvanted vaccine development and developmental and juvenile animal studies. The 10-page draft guidance consolidates and supplements recommendations from various guidances, including the ICH S8 and the FDA's 2006 guidance. Learn More