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Von E to Remain at FDA Until Inauguration Day

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FDA commissioner Andrew von Eschenbach says he will remain at his post until Inauguration Day.

Drug-safety Staff Morale Improvement for $1.5 million?

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Reps. Barton and Shimkus ask questions about a $1.5 million FDA contract to improve morale in the CDER drug safety staff.

Advisors Find New Female Condom Approvable

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FDAs Obstetrics and Gynecology Devices Advisory Committee says the Female Health Co.s FC2 female condom is approvable.

FDA Approves Scherings Combination for Pediatric Hep. C

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FDA approves Schering-Ploughs Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy for use in previously ...

Genta to Appeal FDAs Genasense NDA Rejection

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Genta says it intends to appeal FDAs recent decision not to approve an amended NDA for Genasense, indicated for combination use wi...

Guidance on Sterile Device Submission Info

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Federal Register Notice: FDA releases a draft guidance on submission and review of sterility information in 510 (k) submissions fo...

Outdated Federal Register Proposed Rules Withdrawn

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Federal Register Notice: FDA withdraws certain outdated advance notice of proposed rulemaking and proposed rules published in the ...

Hi-Tech Loses Ophthalmic Drug Injunction

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Hi-Tech loses its court bid for marketing exclusivity for generic Cosopt.

FDA to Test Ad Price Incentives

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FDA plans to test the impact of price offers embedded in DTC print ads on consumer perception of product risks and benefits.

Info on Electronic Device Submissions Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on requirements for device establishments to register and ...