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Federal Register Notice: FDA is making available a draft guidance for industry entitled Circumstances that Constitute Delaying, De...