On September 4, 2025, the U.S. Food and Drug Administration (“FDA”) announced plans to begin releasing complete response letters (“CRLs”) “promptly” after it issues them to sponsors, rather than waiting until after approval....more
9/12/2025
/ Administrative Procedure Act ,
Biologics ,
Clinical Trials ,
Disclosure Requirements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
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Trade Secrets ,
Transparency
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more