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CDER Releases Data Standards Strategy

07/15/2013

Federal Register Notice: CDER is making available the CDER Data Standards Strategy (version 1.0) and the CDER Data Standards Strat...

FDA to Award Cooperative Agreement for Trade Development

07/15/2013

Federal Register Notice: FDA intends to receive and consider a single source application for awarding a cooperative agreement in F...

Guidance on Pediatric Study Plans

07/15/2013

Federal Register Notice: FDA is making available a draft guidance for industry entitled Pediatric Study Plans: Content of and Proc...

FDA Posts May NADA, ANADA Approvals

07/15/2013

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during M...

Info on Device Sterilization Sent to OMB

07/15/2013

Guidance on Delaying, Denying a Drug Inspection

07/15/2013

Federal Register Notice: FDA is making available a draft guidance for industry entitled Circumstances that Constitute Delaying, De...

Panel to Discuss Counterfeit, Unapproved Drugs

07/15/2013

Federal Register Notice: FDA’s Risk Communications Advisory Committee will meet 8/16, from 9 a.m. to 5 p.m. at the FDA White...

Panel Meeting Canceled

07/15/2013

Federal Register Notice: FDA has canceled the 7/17 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee due to...

Info on Mammography Standards Sent to OMB

07/08/2013

Federal Register Notice: FDA’s proposed collection of information, “Mammography Quality Standards Act Requirements,&rd...

Guidance on Cellular and Gene Therapy Product Trials

07/08/2013

Federal Register Notice: FDA is making available a draft guidance entitled Guidance for Industry: Considerations for the Design of...