54 Product-Specific Drug Guidances Out

FDA has released additional draft and revised draft product-specific drug guidances. A Federal Register notice to be published 9/14 says the guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs. Comments on the drafts will be accepted for 60 days.

FDA commissioner Scott Gottlieb says that by explaining the agency’s current thinking and expectations on how to develop specific generic drug products that are therapeutically equivalent to the brand name drug products, FDA can provide an efficient path for the products to receive regulatory approval to enter the market, especially when they don’t have any generic competition.

The batch contains 42 new guidances and 12 revised guidances. Of the 54, 12 are new draft guidances and six are revised guidances for complex drug products, including 14 products that do not have generic competition.