The FDA continues to break records in approving generics to ramp up competition in the U.S. drug market. In fiscal 2019, the agency approved 1,171 generic drug approvals – 935 full approvals and 236 tentative approvals. That breaks fiscal 2018's record of 971 approvals, Acting FDA Commissioner Ned Sharpless said. The 2019 approvals included 125 applications for first generics of drugs that had no generic competition.
The FDA finalized its 2018 guidance describing the waivers, reductions and refunds for drugs and biologics permitted under the user fee provisions of the Federal Food, Drug & Cosmetics Act. The guidance discusses the procedures for submitting requests for the waivers, reductions, refunds, and reconsiderations or appeals. It also clarifies issues such as user fee exemptions for orphan drugs.