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Pilot Project for Drug REMS in SPL Format

10/06/2015

Federal Register Notice: FDA is announcing a pilot project for submitting final approved Risk Evaluation and Mitigation Strategies...

FDA Posts List of Approved PMAs

10/06/2015

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 Fluroquinolone Antibacterials

10/01/2015

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

Panel to Discuss Bulk Drug Substance Nominees

10/01/2015

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/...

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 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...

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 Plans Conference on Drug-Induced Liver Injuries

12/19/2014

Federal Register Notice: FDA will hold a public conference 3/18-19/15 entitled “Serious Drug-Induced Liver Injury (DILI): Th...

Info on Form FDA 3674 Sent to OMB

12/19/2014

Federal Register Notice: FDA’s proposed collection of information, “Certification To Accompany Drug, Biological Produc...