Regulatory Alert

As trust in federal health agencies has withered over the last few months, a group of Black physicians has been working on an antidote: creating their own expert task force to independently vet regulators' decisions about Covid-19 drugs and vaccines as well as government recommendations for curbing the pandemic. Organized by the National Medical Association - founded in 1895 as an answer to racist professional societies excluding Black doctors - the committee is meant to safeguard against any unscientific guidance from the Centers for Disease Control and Prevention and the Food and Drug Administration. Learn More

In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation's health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation's foods, medicines, medical devices and other products, including vaccines. Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power "is reserved to the Secretary." The bulletin was sent to heads of operating and staff divisions within H.H.S. It's unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Learn More

The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric antigen receptor (CAR)-T cell therapies. The "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" was originally issued in 2012 but underwent revision and consultation from July 2018-July 2019. The revised version is expected to be adopted in October and published in November, according to Ana Hidalgo-Simon, MD, PhD, head of advanced therapies at EMA. Learn More

Investigators should use a patient-reported outcomes approach, with an emphasis on electronic data collection, in their research on therapies to treat or prevent COVID-19, according to a new guidance from the US FDA. The guidance, which is effective immediately during the public health emergency of the coronavirus pandemic, outlines how to capture disease-related symptoms in clinical trials focusing on COVID-19 prevention or treatment for outpatient adults and adolescents. Learn More

Health and Human Services Secretary Alex Azar led an escalating pressure campaign against his own Food and Drug Administration this spring and summer, urging the agency to abandon its responsibility for ensuring the safety and accuracy of a range of coronavirus tests as the pandemic raged. Then in late August, Azar took matters into his own hands. Overriding objections from FDA chief Stephen Hahn, Azar revoked the agency's ability to check the quality of tests developed by individual labs for their own use, according to seven current and former administration officials with knowledge of the decision. Learn More

A Phase 1 trial assessing Cellectis' investigational CAR T-cell therapy, UCARTCS1A, has been placed on hold by the U.S. FDA. The MELANI-01 study (NCT04142619) was assessing the safety and clinical activity of different doses of UCARTCS1A, administered in a single infusion, with the aim of determining the optimal dose for further testing. The clinical hold came after one patient, who received the second dose level of the therapy, died from cardiac arrest during the study. Cellectis is working closely with the FDA to lift this clinical hold, which will require the company to make changes to the study's protocol to enhance participants' safety. Learn More

A new temporary guidance for drug and biologics manufacturers from the US FDA details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic. "This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply," said FDA in announcing the availability of the temporary guidance. Learn More

The head of the US FDA, Commissioner Stephen Hahn, said he has "no intention" of overruling career scientists at the agency on an approval of a coronavirus vaccine even though he has the authority. He went on to add that any vaccine data released will be discussed publicly by an advisory committee of outside experts and that Peter Marks, who runs the FDA division that oversees vaccine approvals, will ultimately make a recommendation. "I have complete and absolute confidence in the scientists at the FDA and the decision-making that they have here," he added. Learn More

Manufacturers can request emergency use authorizations under the public health emergency of the coronavirus pandemic for multi-analyte respiratory panels, the US FDA clarified this week. The agency added a new item to its questions and answers (Q&As) for laboratories and manufacturers of tests for SARS-CoV-2, the virus that causes COVID-19. The new Q&A cites "the overlap in signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza." Multi-analyte panels for respiratory infections, noted the agency, "are useful when multiple respiratory pathogens are circulating at the same time, as is expected with the upcoming flu season." Learn More

An Indonesian firm was warned by the US FDA for failures in product testing and method validation, among other breaches of current good manufacturing practice (CGMP). In a November 2019 inspection of PT. MegaSura Mas, FDA inspectors found that some assays conducted for batch releases of an over-the-counter product were performed after the batches were released. According to the warning letter, the firm also used an assay testing method for the active ingredient in the finished product that was not a US Pharmacopeia (USP) method, nor was it validated by high-performance liquid chromatography. Learn More

Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. FDA has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply. Learn More

In its suite of post-transition guidance's released this week, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on January 1st, 2021. The guidance, which largely mirrors the "no deal" scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing authorizations to how to register new packaging information for medicines after the transition date. Learn More

A second Trump administration appointee has been ousted at the FDA in the wake of the agency's botched announcement about an experimental therapy for COVID-19, which medical experts said damaged the health regulator's credibility with the public. An FDA spokesperson confirmed this week that John "Wolf" Wagner, a political appointee installed by the White House earlier this summer, is no longer heading the agency's office of external affairs. Instead, Heidi Rebello, a longtime FDA career official, has stepped into the position on an acting basis, overseeing all FDA public communications. Politico first reported the news. Learn More

The US FDA last month warned Mylan Laboratories and Acella Pharmaceuticals over good manufacturing practice (GMP) violations. The FDA's warning letter to Mylan cites the company for issues related to its cleaning procedures and handling of recovered solvents. While the warning letter to Acella Pharmaceuticals follows a three-week inspection that ran from December 2019 into January 2020 and uncovered issues with the company's NP Thyroid products that led to the company recalling 13 lots of the tablets due to super potency in May. The warning letter also cites Acella for its quality unit's failure to adequately oversee its CMO. Learn More

FDA Commissioner Stephen Hahn said in a new interview that he is willing to fast-track a coronavirus vaccine before clinical trials are complete if it is determined to be "appropriate." Hahn stressed politics would play no part in such a move, telling the Financial Times that "this is going to be a science, medicine, data decision." "It is up to the sponsor to apply for authorization or approval, and we make an adjudication of their application," Hahn told the newspaper while discussing scenarios in which the FDA grants vaccine approval. "If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination." Learn More

The US FDA has released its latest batch of product-specific guidance's, posting 19 new and 17 revised draft guidance's, bringing the total number of product-specific guidance's issued by the agency to 1,938. The guidance's, which FDA posts quarterly, are intended to promote generic competition by clarifying the agency's expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far this year FDA issued nearly 150 product-specific guidance's. Learn More

Cassiopea has won approval for its first medicine, an acne treatment, from the U.S. FDA, setting the stage for a likely capital increase to support its launch. Winlevi, a twice-daily topical prescription medicine that targets hormones called androgens, won approval for males and females 12 years and older, Cassiopea said. Winlevi reduced acne in trials. The most frequent local reaction was skin redness, or erythema. The drug is expected to be available in the United States in early 2021 and Cassiopea plans to announce the price in the fourth quarter. It did not give sales expectations. Learn More

The US FDA has authorized emergency use of a coronavirus test that costs $5 and can produce results in 15 minutes without the use of any lab equipment. Test-maker Abbott says it could soon manufacture 50 million of the rapid antigen tests per month, which could ease the country's testing bottleneck by greatly increasing overall capacity and the speed at which results arrive. Abbott's test is designed for use within seven days of the onset of symptoms. It gives results on a card reminiscent of the stick used in many over-the-counter pregnancy tests. If one line appears on the card, the patient is negative for the coronavirus; two lines indicates a positive result. Learn More

A quality improvement study led by the US FDA found that over 200 difficult-to-manufacture drug product samples met US standards for dosage unit uniformity and dissolution. The 252 products that were sampled in the largest such study to date included 35 innovator and 217 generic drug samples. In all, the products contained 17 different active pharmaceutical ingredients (APIs) and the samples originated from 46 firms. Adam Fisher, PhD, and his colleagues at the FDA's CDER examined drug products from the US, Canada, Europe, India and the rest of Asia. Learn More

The US this week announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are "critical to the public health during a public health emergency," and the active pharmaceutical ingredients of those drugs. Drugmakers are also now required to report manufacturing volume data annually. Learn More

Novartis has announced that the US FDA has approved Kesimpta® as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide and is a first-choice treatment option for RMS patients1. Kesimpta is the first B-cell therapy that can be self-administered once monthly at home via the Sensoready® autoinjector pen3. Learn More

A US FDA emergency use authorization for blood plasma to treat Covid-19 is on hold, but could still be issued in the near future, Dr. H. Clifford Lane, deputy director at the National Institute of Allergy and Infectious Diseases, told The New York Times. The hold came after a group of federal health officials -- including National Institutes of Health Director Dr. Francis Collins, NIAID Director Dr. Anthony Fauci and Lane -- stepped in to argue the emerging data on the treatment was too weak, the Times reported, citing two senior administration sources. News of the hold led President Trump to suggest that it might be of a political nature and not based on science. Learn More

The US FDA this week issued an immediately effective frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic. For the time being, the FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval and for-cause inspections. For domestic inspections, this means conducting mission-critical inspections on a case-by-case basis or, when it can be done safely, resuming domestic inspections based on priority. Learn More

Poseida announced this week that the FDA paused enrollment in the Phase I clinical study of its prostate cancer treatment P-PSMA-101 following the death of a patient. In a filing with the U.S. Securities and Exchange Commission, Poseida said the patient in question was diagnosed with metastatic castrate-resistant prostate cancer and had failed previous treatment with multiple anti-cancer agents. The direct cause of the patient's death has not yet been determined, but Poseida said the patient developed symptoms consistent with macrophage activation syndrome (MAS), a serious and potentially fatal over-activation of the immune system that has been associated with CAR-T therapies. Learn More

In a new manual of policies and procedures (MAPP) released this week, the US FDA's Center for Drug Evaluation and Research (CDER) explains how and when it will notify applicants when the agency plans to study a product using its Sentinel active risk identification and analysis (ARIA) system. Before the FDA can require a post marketing study or clinical trial for a drug, it must determine whether its ARIA system or adverse event reporting systems would be sufficient to answer the question of interest. In the newly released MAPP, FDA lays out how it will notify applicants when it determines that a study using ARIA would be sufficient to assess a potential serious risk. Learn More

A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. FDA. The method, called SalivaDirect, is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the NBA. SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing. Learn More

Passage Bio's first attempt to develop a GM1 gangliosidosis gene therapy treatment has run into a roadblock in the form of a clinical hold. The company disclosed in its quarterly report this week that the FDA placed a clinical hold pending risk assessments for its experimental treatment PBGM01, which the company is developing in collaboration with the University of Pennsylvania's Gene Therapy Program. In its announcement, Passage Bio said it is evaluating options for conducting additional risk assessments while it awaits official written feedback from the FDA. Learn More

American Gene Technologies (AGT) has announced approval by the FDA to begin Phase 1, the first human clinical trial for AGT's HIV program. AGT will conduct its Phase 1 study at clinical sites in the Baltimore/D.C. area and has named Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University as its initial trial sites. These sites are expected to begin enrollment in September 2020.  AGT hopes to report initial data before the end of the year. Learn More

Dr. Scott Gottlieb is wary of the safety and effectiveness of a new coronavirus vaccine touted by Russian President Vladimir Putin as the world's first drug approved to prevent Covid-19. "I wouldn't take it, certainly not outside a clinical trial right now" where patients are closely monitored, Gottlieb said this week. "They're claiming that it's fully approved, but it's not fully approved." Russia plans to begin its first large-scale, phase three trials of its vaccine today even though health officials have already cleared it for public distribution. Researchers have yet to publish any data on the vaccine trials thus far, including information on the safety, efficacy or possible long-term side effects. Learn More

A new draft guidance from the US FDA gives industry direction in how to assess drug-drug interactions for therapeutic proteins. The guidance, issued jointly by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) recommends that sponsors use a "systematic, risk-based" approach to determine whether their therapeutic protein candidates for investigational new drug applications (INDs) and biologic license applications (BLAs) require drug-drug- interaction studies. The draft document covers therapeutic proteins (TPs) licensed as therapeutic biological products, but the FDA notes that the general concepts could be applicable to other biological products. Learn More

A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US FDA. The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework laid out in a related draft guidance, Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions. Learn More

Since the outbreak of the covid-19 pandemic, developing a safe and effective vaccine has been an urgent worldwide priority: to save lives, and to bolster the public's confidence in returning to a semblance of normal life. That being said, I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and good science. I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment. Learn More

The US FDA this week finalized the guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations. The final guidance comes more than two years after the FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. In the final guidance, FDA further clarifies how it interprets "limited population" by contrasting two examples of drugs, one that would be fit for the LPAD pathway and one that would not. Learn More

Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the COVID-19 pandemic, Stephan Hahn, FDA commissioner, and Anand Shah, FDA deputy commissioner, wrote in a blog post on the FDA website. They highlighted key regulations the agency has promulgated in recent years to support advanced manufacturing, specifically, supporting companies in developing process control measures for continuous manufacturing, supporting developers by addressing technical considerations needed to create gene therapies and the development of "leapfrog" guidance's sharing the agency's thinking on emerging technologies. Learn More

The US FDA, in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a glossary. Biosimilar and interchangeable biological products are included in the searchable online database. The current list of products maintained by CBER will not be further updated by the FDA. The Purple Book Database now contains biosimilar and interchangeable biological products and allergenic, cell and gene therapy, hematologic, and vaccine products. Transition biologic products that were originally approved via New Drug Applications (NDAs) but transitioned to Biologic License Applications (BLAs) also appear in the database. Learn More

Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) have reached a consensus on endpoints that would be acceptable as primary endpoints in randomized controlled trials for therapeutics to treat coronavirus disease (COVID-19). In a teleconference co-chaired by the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), ICMRA members reviewed potential endpoints with the goal of agreeing on acceptable endpoints that could "facilitate rapid and consistent implementation of future clinical trials for COVID-19 medicines across the world." Learn More

The head of the U.S FDA this week said the agency would consider an "emergency use authorization" to expedite getting a vaccine against the Coronavirus strain Covid-19 to millions of Americans. FDA Commissioner Dr. Stephen Hahn said the agency would "consider an emergency use authorization if we felt that the risks associated with the vaccine were much lower than the risks of not having a vaccine and the potential benefit of having a vaccine." The FDA has used several emergency use authorizations in the pandemic as a way to get many diagnostic tests for Covid-19 more quickly to the market than the agency's typical approval process. Learn More

Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US FDA. The draft guidance addresses the reality of oncologic drug development, where investigational therapies are frequently used in combination with other approved treatments, or in conjunction with another investigational drug. Specifically addressed are parenterally administered anticancer drugs under investigation to treat serious and life-threatening cancers. Learn More

At an event marking the launch of Moderna's Phase 3 clinical trial for its mRNA coronavirus vaccine in Miami this week, US FDA Commissioner Stephen Hahn repeated assurances that his agency would not cut corners in approving a COVID-19 vaccine. Hahn's remarks come as some observers have raised concerns that the FDA might be pressured to approve a vaccine before the November election without adequate evidence of safety and efficacy. Officials have also sought to reassure the public that an eventual vaccine will be held to rigorous standards as recent polls have found a significant number of Americans are hesitant about getting a coronavirus vaccine. Learn More

Biotech companies and industry groups are raising questions about the US FDA's recent draft guidance on interpreting sameness of gene therapy products under its orphan drug regulations. The draft guidance, issued for comment in January, explains how the FDA intends to determine the sameness of two gene therapies intended for the same use or indication for the purposes of awarding orphan drug designation and exclusivity. While current regulations "do not elaborate on how the 'same drug' definition applies specifically to gene therapy products," the FDA explains that it will consider the principal molecular structural features of the gene therapies to make its determination. Learn More

Increasing the timely, safe, and cost-effective availability of generic drugs requires that excipient issues be addressed as an integral part of the process, said Priscilla Zawislak, Immediate Past-Chair of International Pharmaceutical Excipients Council (IPEC)-Americas. Zawislak, speaking at the June 21st, 2020 public hearing kicking off the reauthorization process for the third Generic Drug Fees User Amendments (GDUFA III), said that excipient manufacturers are also asking for improvements in communication with FDA on excipient issues, and for formal inclusion of IPEC-Americas in the ongoing GDUFA discussions. Learn More

At its first public meeting in the runup to the reauthorization of the Prescription Drug User Fee Act, the US FDA, industry and other stakeholders this week shed light on their goals for what will be the agency's seventh PDUFA program. The meeting, held fully virtually for the first time due to the COVID-19 pandemic, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA's new drug review program from FY2023-FY2027. Learn More

In its warning letter to Irvine, CA-based CDMO Stason Pharmaceuticals, the U.S. FDA cites the company for product testing and data integrity issues uncovered during a three-week inspection last October. According to THE FDA, the company was not able to assure that temozolomide capsules it produced met dissolution attributes throughout their shelf life. After obtaining out-of-specification (OOS) results for multiple lots of the drug, the company investigated some of the OOS results and had a relaxed dissolution specification for the drug approved by the FDA. However, FDA says Stason's "response was inadequate because did not determine a clear root cause"... Learn More

In a public meeting held via webcast, officials of the US FDA kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which included presentations by members of industry and the public, is the first of many that will shape the agency's third GDUFA program. GDUFA II, authorized in 2017, expires at the end of September 2022. Learn More

The EMA this week issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021. The adoption of the guideline follows a public consultation that kicked off in November 2018, with EMA making mostly minor changes to the guideline aside from revisions to the table listing minimum acceptable quality of water for manufacturing active substances. The EMA says the guideline applies to the manufacture of active substances for both human and veterinary, as well as to advanced therapy medicinal products (ATMPs), and should be consulted for new marketing authorization applications. Learn More

As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19. To date, three therapeutics are approved to treat COVID-19: dexamethasone in the United Kingdom; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in Japan and Australia. This tracker, created and maintained by RAPS, was last updated on July 17th, 2020 to include new information on Veklury, dexamethasone, Avigan, RLF-100, INOpulse, JS016, and Actemra (tocilizumab). Learn More

The House Energy and Commerce Committee this week advanced 17 health-related bills for consideration by the House, several of which have implications for the US FDA. Among them is H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019. It would direct the U.S. FDA to designate national centers of excellence in continuous pharmaceutical manufacturing that would work with the agency and industry "to craft a national framework for continuous manufacturing implementation." The bill would provide $80 million in appropriations for designated centers of excellence each year from FY2021-2025. Learn More

The US FDA has added three more hand sanitizers to its rolling list of products recalled because of possible contamination with a toxic chemical. In total, over 65 of the cleansers have now tested positive for methanol, which can be poisonous if absorbed through the skin or ingested, according to the FDA's latest update. A majority of the products appear to have been manufactured in Mexico, with recalls issued by the manufacturer or distributor. The FDA's continuously updated list, which climbed to 59 products as of July 12, began in June when the regulator observed an increase in hand sanitizers that purportedly contained ethanol but tested positive for methanol contamination. Learn More

At a virtual briefing this week, several experts told members of the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy that a transparent process and advisory committee review will be key to the effective rollout of a vaccine to prevent coronavirus disease (COVID-19). The briefing comes just two weeks after the US FDA issued guidance on the development and licensure of vaccines against SARS-CoV-2, the virus that causes COVID-19, and at a time when some of the most advanced vaccine candidates are moving into Phase 3 trials. Learn More

Last week, the US FDA's Center for Biologics Evaluation and Research (CBER) withdrew 20 draft and final guidances, more than half of which date back to the 1980s and 1990s. Many of the withdrawn guidance's relate to blood and blood products, donor screening and HIV. Among the guidances are a Y2K-era guidance on handling the year 2000 date change for computer systems and software applications used to manufacture blood products and a 2003 guidance on screening donors for severe acute respiratory syndrome (SARS). Learn More

Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US FDA has announced that it plans to resume on-site domestic inspections beginning the week of July 20th, 2020. As a safety measure, the FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future. The announcement comes nearly two months after the agency said it will implement a phased approach to restarting surveillance inspections and four months after the agency halted its domestic inspection program. The FDA said it will prioritize which inspections it conducts in the coming months using a new risk assessment system. Learn More

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