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Info on MedWatch Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the MedWatch reporting program to the Office of Manag...

Meeting to Discuss Biosimilar Biologic User Fees

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Federal Register Notice: FDA plans a public meeting 12/16 to discuss the recommendations for a user fee program for biosimilar bio...

Trade Groups Back Trial Monitoring Guidance

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AdvaMed, PhRMA, and BIO voice support for FDAs draft guidance promoting a risk-based approach to clinical investigation monitoring...

Sebelius Imposes Her Plan B Science on FDAs

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HHS secretary Kathleen Sebelius orders FDA to reverse its internal decision and deny a Teva sNDA to allow Plan B One-Step to be ma...

FDA Extends Taliglucerase Alfa Review

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FDA extends the PDUFA review date for Protalaix taliglucerase alfa NDA to 5/1/12.

FDA Not Reading Kesslers Yasmin Comments

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FDA says a report by former FDA commissioner David Kessler cant be used at a 12/8 hearing on Yasmin contraceptive safety because i...

Guidance on Premarket Submissions for Artificial Pancreas Devices

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Federal Register Notice: FDA releases a draft guidance on developing premarket submissions for artificial pancreas device systems.

FDA Bars Wolfe From Yasmin Safety Hearing Panel

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FDA says Public Citizens Sidney Wolfe has an intellectual conflict of interest that bars him from participating on the panel of an...

FDA Eases REMS for Nplate and Promacta

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FDA says it is easing REMS restrictions for Nplate and Promacta by removing program registration requirements.

Advisors Asked to Comment on Yasmin Studies, Labeling

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FDA asks members of two advisory committees to consider the risk-benefit profile and labeling for Bayer combination oral contracep...