News & Analysis as of

Regulatory Requirements › Enforcement Actions › Abbreviated New Drug Application (ANDA)

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

ArentFox Schiff on

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

2 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:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide