Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
BridgeBio’s recently announced sale of an FDA Priority Review Voucher for $110 million reflects a robust secondary market for these regulatory fast passes. Prices for Priority Review Voucher (“PRVs”) reflect the high stakes...more
On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more