The U.S. FDA this week released its latest batch of product-specific guidance documents to support the development of generic drugs, with 25 new and nine revised draft guidances. HIV antiretrovirals and antibiotics topped the list of new draft guidances with a total of five, followed by drug products containing active ingredients to treat ophthalmic ailments and cancers. The product-specific guidance is part of the agency’s push to spur generic competition. Each guidance provides product-specific recommendations to aid manufacturers in the design of bioequivalence studies in support of abbreviated new drug applications. Learn More