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Latest posts

Last updated 4 days ago

FDA Acts to Protect Children from Unapproved Fluoride Drug Products

4 days ago

The U.S. Food and Drug Administration today announced actions to restrict the...

FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs

6 days ago

The U.S. Food and Drug Administration (FDA) today announced significant action to...

FDA Issues Emergency Use Authorization for New World Screwworm Drug for Dogs

11 days ago

FDA issued an Emergency Use Authorization (EUA) concluding that based on the...

FDA Publishes Filing Checklists to Prevent Submission Delays

12 days ago

The U.S. Food and Drug Administration today made public filing checklists used...

FDA Awards First-Ever National Priority Vouchers to Nine Sponsors

19 days ago

The U.S. Food and Drug Administration today announced 9 voucher recipients under...

FDA Conditionally Approves First Drug for Prevention and Treatment of New World Screwworm Infestations in Cattle

about 1 month ago

The U.S. Food and Drug Administration conditionally approved Dectomax-CA1 (doramectin injection) injectable...

A Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging Retailers to Stop Selling Illegal Vapes

about 1 month ago

As part of the FDA’s broader strategy to combat the crisis of...

FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia

about 1 month ago

Today, the U.S. Food and Drug Administration authorized marketing of the Essilor...

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

about 1 month ago

The U.S. Food and Drug Administration today announced that it has eliminated...

FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy

about 1 month ago

The U.S. Food and Drug Administration today initiated the process for a...

FDA Takes Action to Make a Treatment Available for Autism Symptoms

about 1 month ago

The U.S. Food and Drug Administration today initiated the approval of leucovorin...

FDA Grants Accelerated Approval to First Treatment for Barth Syndrome

about 2 months ago

The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide)...