Posted by Michael Wonder on 15 Aug 2019
Growing numbers of priority and competitive ANDAs under review as approvals trickle in
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic competition and speeding the approval of priority generic drugs.
The FDA Reauthorization Act of 2017 (FDARA) included provisions to shorten the reviews of certain abbreviated new drug applications (ANDAs) by two months under a new priority review program as well as a new competitive generic therapy (CGT) designation intended to increase competition for drugs with only one generic competitor on the market.
While priority ANDAs are granted shorter review times, FDA explained in draft guidance earlier this year that while it may take actions to expedite the review of certain CGTs, “an expedited review does not result in a shorter [Generic Drug User Fee Amendments] GDUFA goal date.” The guidance also explains steps FDA may take to expedite the development and review of CGTs, which include product development meetings, pre-submission meetings and mid-review cycle meetings.
