In an attempt to advance drugs treating rare diseases, the U.S. Food and Drug Administration (FDA or “agency”) launched a new pilot program titled ‘Support for clinical Trials Advancing Rare disease Therapeutics’ – also known as START – on September 29, 2023. According to an announcement from the agency, a limited number of sponsors are given the opportunity to participate in extra meetings with the FDA.
Eligibility for the program extends to a range of products. Notably, these include biological drugs regulated by the Center for Biologics Evaluation and Research (CBER) that are gene therapies. As stipulated by Hogan Lovells, these additional meetings with the FDA are a boon for those sponsors introducing novel drugs aimed at rare diseases.
This START initiative by the FDA is, no doubt, an effort to propel forward in the field of rare disease therapeutics. By providing more interaction opportunities with the agency, sponsors are given a clearer pathway to navigate through regulatory concerns and expedite the development and delivery of novel drugs for rare diseases.