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Comments Sought on Influenza Pandemic Reporting Guidance

08/11/2014

Federal Register Notice: FDA is seeking public comments on the guidance that discusses the agency’s approach to enforcing ad...

Comments Sought on CGMP Dispute Guidance

08/11/2014

Federal Register Notice: FDA is seeking public comment on the proposed collection of information resulting from the guidance to ma...

Comments Sought on Blood Establishment Regs

08/11/2014

Federal Register Notice: FDA is seeking comments on the information collection requirements relating to the blood establishment re...

FDA Posts June NADA, ANADA Approvals

07/31/2014

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during J...

FDA Posts FY 2015 Device User Fee Rates

07/30/2014

Federal Register Notice: FDA is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) ...

OMB OKs Info on Safety Communication

07/30/2014

Federal Register Notice: FDA’s collection of information entitled “FDA Safety Communication Readership Survey,” ...

Guidance on CDRH Appeals Processes

07/30/2014

Federal Register Notice: FDA is making available a guidance entitled Center for Devices and Radiological Health (CDRH) Appeals Pro...

Panel to Hear Research Updates

07/30/2014

Federal Register Notice: FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet 9/18 from 1 p.m. to 4 p.m. T...

Guidance on Vaccine Safety Report E-Submissions

07/18/2014

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Providing Submissions in Electro...

Tobacco Center Initiates Site Tours Program

07/17/2014

Federal Register Notice: FDA’s Center for Tobacco Products, Office of Science is inviting participation in its Site Tours Pr...