Public Meeting on Narcolepsy Drug Development
07/19/2013
FDA Withdraws NDAs, ANDAs
07/19/2013
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Federal Register Notice: FDA is making available a draft guidance for industry entitled Circumstances that Constitute Delaying, De...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...
FDA Proposes Authority to Detain Drugs
07/15/2013
Federal Register Proposed rule: FDA is proposing a regulation to implement administrative detention authority for drugs intended f...
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...
