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FDA Corrects Regulation on Hearing Process

08/25/2008

Federal Register Final rule: FDA is amending a regulatory hearing process regulation to correct an inaccurate citation, and regula...

FDA/PDA Joint Meeting

08/22/2008

Federal Register Notice: FDA will sponsor a meeting 9/8-12, “Achieving a Future Vision at the 2008 Parenteral Drug Associati...

Safety Labeling Changes Reg Amendments

08/22/2008

Federal Register Final rule: FDA is amending its regulations regarding changes to an approved NDA, BLA, or PMA so that a supplemen...

Guidance on Antimicrobial Drugs for Bronchitis

08/22/2008

Federal Register Notice: FDA is making available a draft guidance for industry, Acute Bacterial Exacerbations of Chronic Bronchiti...

Comments Extended on Cephalosporin in Animals

08/18/2008

Federal Register Extension of comment period: FDA is extending to 11/1 the comment period for an order prohibiting the extralabel ...

Guidance on OTC Skin Product Labeling

08/04/2008

Federal Register Notice: FDA is making available a draft guidance, Labeling OTC Skin Protectant Drug Products. An OTC skin protect...

FY 2009 Device User Fees Posted

08/01/2008

Federal Register Notice: FDA is publishing the fee rates and payment procedures for medical device user fees for fiscal year 2009....

FDA Posts FY 2009 Prescription Drug User Fees

08/01/2008

Federal Register Notice: FDA is publishing the rates for prescription drug user fees for fiscal year 2009. Application fees for an...

Workshop on Thermal Ablation for Breast Cancer

07/21/2008

Federal Register Notice: FDA will sponsor a public workshop 9/15 to discuss the issues associated with developing and implementing...

FDA?s New Warning Tool ? the Press Release?

07/10/2008

[Report by John Scharmann*] Has FDA Office of Enforcement director David Elder added a new industry warning tool to his armory? It...