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Workshop on Cellular Therapies/Regenerative Medicine

07/22/2013

FDA Withdraws Guide on Frozen Plasma

07/22/2013

Federal Register Notice: FDA is withdrawing a compliance policy guide entitled “Sec. 253.100 — Use of Units of Plasma ...

Public Meeting on Narcolepsy Drug Development

07/19/2013

FDA Withdraws NDAs, ANDAs

07/19/2013

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...

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Federal Register Notice: FDA is making available a draft guidance for industry entitled Pediatric Study Plans: Content of and Proc...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