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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Federal Register Notice: FDA is making available a draft guidance for industry entitled Pediatric Study Plans: Content of and Proc...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Federal Register Notice: FDA is making available a draft guidance for industry entitled Circumstances that Constitute Delaying, De...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...

Guidance on Certification for Medical Gases

12/18/2012

Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...

Guidance on Enrichment Strategies in Trials for NDAs, BLAs

12/17/2012

Comments Sought on HDE Applications

12/17/2012

Federal Register Notice: FDA is seeking public comment on information to accompany humanitarian device exemption applications and ...

Guide on RFID Studies is Extended

12/17/2012