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FDA Sends Info on BLA Changes to OMB

07/21/2005

Federal Register Notice: FDA’s proposed collection of information, “General Licensing Provisions: Biologics License Application, C...

FOIA Exemptions Put into Regs

07/21/2005

Federal Register Final rule: FDA is amending its public information regulations to implement the exemptions contained in the Freed...

FDA Corrects Error in Phibro Roxarsone NADA Approval

07/21/2005

Federal Register Final rule: FDA is correcting a 2/23/04 Federal Register final rule that listed approval of Phibro Animal Health’...

Guidance on Dispute Resolutions for CVM Products

07/19/2005

Federal Register Notice: FDA is making available a document entitled Guidance for Industry: Dispute Resolution Procedures for Scie...

Latest FDA Warning Letters

07/19/2005

Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following e...

FDA OKs Pfizer sNADA for Finfish

07/18/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental NADA filed by Pfize...

Draft Guidance on Emergency Use of Medical Products

07/11/2005

Federal Register Notice: FDA is making available a draft guidance entitled Emergency Use Authorization of Medical Products. The dr...

Cellular, Tissue and Gene Therapies Advisory Panel to Meet

07/11/2005

Federal Register Notice: FDA will hold a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee 7/29 via teleconfer...

Panel to Discuss Pozen Migraine Treatment

07/11/2005

Federal Register Notice: FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet 8/4, from 8 a.m. to ...

FDA, Howard University Sign MOU

07/11/2005

Federal Register Notice: FDA is providing notice of a memorandum of understanding between FDA and Howard University, Washington, D...