ARTICLE | Politics, Policy & Law

BIO calls for FDA flexibility on accelerated approval requirements

Trade association opposes routine requirement for ongoing confirmatory trials

January 26, 2023 6:00 PM UTC

One of BIO’s top priorities is preventing FDA from routinely requiring that trials confirming clinical benefit be under way before it grants accelerated approval. Many small biotechs do not have sufficient funds to start confirmatory trials prior to approval, according to BIO. The trade association’s arguments are unlikely to resonate at the agency.

FDA officials believe that allowing sponsors to defer launching confirmatory trials to after accelerated approval can create unacceptable risks for patients because it can increase the time ineffective or unsafe drugs are on the market. ...