Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Sprout Pharmaceuticals is once again under fire from the FDA’s Office of Prescription Drug Promotion (OPDP). | Sprout ...

Mr. Jon E. RiceActing DirectorOffice of National Drug Control PolicyExecutive Office of the President Washington, D.C. 20503 RE: 2026 National Drug Control Strategy Dear Mr. Rice: The R Street ...

AACE pharmaceuticals was slammed in a warning letter by the FDA that cited significant violations by its contract manufacturer Brassica Pharma, including sanitary conditions and made up lab records.

Upon preliminary review, the FDA determined that the BLA ... "Based on our understanding of the letter, we are confident we can thoroughly address the Agency’s request and expect to resubmit ...

Savara Receives Refusal to File (RTF) Letter From the U.S. Food ... to request a Type A meeting with the FDA, our confidence in our ability to thoroughly address the Agency’s request, our ...

Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration ... our ability to address the FDA’s request and successfully meet the requirements for resubmission; ...

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Bold elegance meets Eastern minimalism in this stunning nail art featuring crisp white bases adorned with striking black ...

CDSCO, DAHD to form JWG to monitor use of antimicrobials in animals: Gireesh Babu, New Delhi Tuesday, June 10, 2025, 08:00 Hrs [IST] In an effort to control the use of antimicrobi ...