U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on September 12, 2025 - 21:30 GMT

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

For Immediate Release: September 12, 2025 The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s …

Distribution channels: Food & Beverage Industry

Published on September 12, 2025 - 17:46 GMT

FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome

FDA News Release Agency exercises regulatory flexibility to address unmet need for rare, life-threatening disease For Immediate Release: December 09, 2025 The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first …

Distribution channels: Food & Beverage Industry

Published on September 12, 2025 - 17:08 GMT

TBC Distribution Corporate Recalls Lucky Foods Brand Cinnamon Powder Because of Possible Health Risk

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on September 12, 2025 - 16:28 GMT

First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity

For Immediate Release: December 09, 2025 The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program, marking the first approval achieved …

Distribution channels: Food & Beverage Industry

Published on September 12, 2025 - 16:10 GMT

BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels: Food & Beverage Industry

Published on September 12, 2025 - 14:36 GMT

How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product

CDER Researchers have been investigating how pharmacokinetic (PK) modeling can support a determination of bioequivalence (BE) for topical drug products. In the case of a generic diclofenac sodium topical gel, 1%, CDER found that physiologically based …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2025 - 13:07 GMT

Annual Licensure Reporting by Wholesale Drug Distributors and Third-Party Logistics Providers

Submit an annual report to FDA Search the annual reporting database Download the database file Annual Licensure Reporting Requirements Wholesale drug distributors and third-party logistics providers must be appropriately licensed and report licensure …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2025 - 10:57 GMT

Lil’ Turtles Issues a Voluntary Recall Due to Undeclared Milk Allergen

Summary Company Announcement Date: December 05, 2025 FDA Publish Date: December 09, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Undeclared Milk Company Name: Lil’ Turtles …

Distribution channels: Food & Beverage Industry

Published on September 12, 2025 - 09:25 GMT

Seaway Pharma Inc. - 717355 - 12/01/2025

Delivery Method: VIA UPS Return Receipt Requested Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Venkata R. Gogineni, Ph.D. Seaway Pharma Inc. 5 County Route 42 Massena, NY 13662 United States Issuing Office: Office of Manufacturing …

Distribution channels: Healthcare & Pharmaceuticals Industry