FDA issues 54 product-specific guidances to promote generic drug access and drug price competition

FDA announced on Thursday more than four dozen new product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs.

FDA announced on Thursday more than four dozen new product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The 54 product-specific guidances include 42 new guidances and 12 revised ones that, when finalized, will reflect the agency's "current thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs," FDA said. FDA Commissioner Scott Gottlieb, MD, noted: "By explaining our current thinking and expectations on how to develop specific generic drug products that are therapeutically equivalent to the brand name drug products, we provide an efficient path for these products to receive regulatory approval to enter the market, especially when they don't currently have any generic competition. Today, we're releasing detailed guidance on recommendations regarding how to develop generic versions of 15 drugs that don't currently face any generic competition." FDA said that it is working to ensure that its policies, regulations, and scientific standards "keep pace with the evolving science around developing generic versions of these complex products so that patients have access to affordable medicines."