Gottlieb: FDA To Develop Generic Review Guide, Submission Guidance

FDA Commissioner Scott Gottlieb announced Tuesday (July 18) that by the end of the year FDA will develop a new internal policy guide for generic reviewers, in hopes of focusing FDA reviews on validating industry studies rather than redoing those studies. The agency will also issue guidance for industry on best practices for submitting Abbreviated New Drug Applications (ANDAs). Both documents are part of the agency's "Drug Competition Action Plan," which aims to address high drug prices by encouraging generic...