Denial Of Drug’s Fast Track Application Was Not An Error, D.C. Circuit Affirms

( December 19, 2024, 9:07 AM EST) -- WASHINGTON, D.C. — The U.S. Food and Drug Administration’s denial of a pharmaceutical company’s application for a fast-track approval of its new drug was not arbitrary and capricious, the District of Columbia Circuit U.S. Court of Appeals held, affirming a summary judgment award to the FDA....