News & Analysis as of

Administrative Procedure Act Clinical Trials Regulatory Reform

Ropes & Gray LLP

FDA Makes Good on Promise to Publish CRLs for Unapproved Drugs and Biologics

Ropes & Gray LLP on

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

1 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide