FDA Urges Monograph Updates During Generic Reviews To Speed Access

FDA took steps Wednesday (July 10) to reduce waiting periods in the generic drug approval process by encouraging industry to propose revisions to United States Pharmacopeia (USP) monographs while applications are pending agency approval. By working simultaneously with FDA and USP, generic drug makers could speed up access to generic medicines, which in turn could help lower drug prices, FDA Acting Commissioner Ned Sharpless says. In draft guidance released Wednesday, FDA encourages drug makers to use USP’s Pending Monograph Process...