FDA: Inactive Ingredient Database Can Cut Time Off Generic Drug Reviews

FDA took another step to help speed up access to generic drugs by publishing draft guidance that explains how drug makers can better use the Inactive Ingredient Database (IID) in drug development, including to evaluate the safety of inactive ingredients, also known as excipients. FDA Acting Commissioner Ned Sharpless said better use of the IID would reduce unnecessary wait time in bringing generic drugs to market. FDA also plans to upgrade the database by Oct. 1, 2020, as it pledged...