The FDA has released 21 revised and 13 new product-specific draft guidelines designed to promote the development of generic drugs, bringing the total number of such guidelines issued by the agency to 1,974. The guidelines explain the FDA's expectations for the studies required to prove the equivalence of a generic drug to a reference-listed drug.
FDA releases 34 guidelines to foster generics competition
Sign up for AIChE SmartBrief
News for chemical engineers
Get the intelligence you need: news and information that is changing your industry today, hand-curated by our professional editors from thousands of sources and delivered straight to your inbox.