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FDA Posts List of Approved PMAs


Federal Register Notice: FDA is publishing a list of PMAs that have been approved to inform the public of the availability of safe...

Panel to Discuss Bulk Drug Substance Nominees


Federal Register Notice: FDA’s Pharmacy Compounding Advisory Committee will meet 10/27, from 8 a.m. to 5:30 p.m., and on 10/...

Panel to Discuss Fluroquinolone Antibacterials


Federal Register Notice: FDA’s Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory C...

FDA Seeks Participants for Biosimilar Act Reauthorization


Federal Register Notice: FDA is requesting that industry trade associations, whose members include drug companies currently engage...

Cardiac Ablation Remote into Class 2


Federal Register Final order: FDA is classifying the steerable cardiac ablation catheter remote control system into Class 2 (speci...

Guidance on Veterinary Feed Directive Q&A


Federal Register Notice: FDA is making available a small entity compliance guide and guidance for industry entitled Veterinary Fee...

FDA Permanently Debars Huda


Federal Register Notice: FDA is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Syed Huda fr...

FDA Sends Info on Drug Supply Chain to OMB


Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Drug Supply Chain Securit...

FDA to Destroy Certain Imported Drugs


Federal Register Final rule: FDA is implementing its authority to destroy a drug valued at $2,500 or less (or such higher amount a...

FDA Sets Fees for Tropical Disease Priority Review


Federal Register Notice: FDA is announcing the fee rates for using a tropical disease priority review voucher for fiscal year 2016...