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FDA Seeks Participants for Biosimilar Act Reauthorization

09/30/2015

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

Cardiac Ablation Remote into Class 2

09/30/2015

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

09/30/2015

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

FDA Permanently Debars Huda

09/16/2015

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

09/15/2015

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

FDA to Destroy Certain Imported Drugs

09/15/2015

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

09/14/2015

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

FDA Issues EUA for Ebola Diagnostic

09/14/2015

Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detection of the Ebol...

Guidance on Provisional Tobacco Product Enforcement

09/14/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Enforcement Policy for Certain (Provisional) Tob...

Panel to Discuss Organon NDA

09/14/2015

Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet 11/6, from 8 a.m. to 5 p....