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CDER Plans Workshop on Liver Disease

07/31/2013

Panel to Discuss Patient Preferences at CDRH

07/29/2013

Federal Register Notice: FDA will hold a public workshop 9/18-19: “The Patient Preference Initiative: Incorporating Patient ...

OMB OKs Info on Tobacco Sale Restrictions

07/25/2013

Federal Register Notice: FDA’s collection of information entitled “Regulations Restricting the Sale and Distribution o...

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 ...

Workshop on Cellular Therapies/Regenerative Medicine

07/22/2013

FDA Withdraws NDAs, ANDAs

07/19/2013

Public Meeting on Narcolepsy Drug Development

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Federal Register Notice: FDA is making available a draft guidance for industry entitled Circumstances that Constitute Delaying, De...