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Info on Fast Track Programs Sent to OMB

08/25/2008

Federal Register Notice: FDA’s proposed collection of information, Guidance for Industry: Fast Track Drug Development Progra...

FDA Proposes Info Collection on Drug Use in Pregnancy

08/25/2008

Federal Register Notice: FDA submits a proposed collection of information, “Mental Models Study of Communicating With Health...

Public Hearing on Pediatric OTC Cough/Cold Drugs

08/25/2008

Federal Register Notice: FDA will hold a public hearing 10/2 to obtain input on over-the-counter cough and cold drugs marketed for...

Info Sent to OMB on Certifications Accompanying Applications

08/25/2008

Federal Register Notice: FDA’s proposed collection of information, “Certification to Accompany Drug, Biological Produc...

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...

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Federal Register Notice: FDA is making available a draft guidance for industry, Acute Bacterial Exacerbations of Chronic Bronchiti...

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...

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Federal Register Notice: FDA is making available a draft guidance, Labeling OTC Skin Protectant Drug Products.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