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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.

FDA OKs Boston Scientific Stent for Renal Arteries

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FDA approves a Boston Scientific PMA for the Express SD Renal Monorail Premounted Stent System for use in certain renal arteries l...

FDA Tentatively OKs ANDA for Generic Miacalcin

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FDA tentatively approves a MDRNA ANDA for a generic copy of Novartis Miacalcin.

FDA Class 1 Recalls for 2 Devices

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FDA issues Class 1 recalls for two unapproved devices for which claims have been made to treat cancer, migraines, and other diseas...

FDA Approves Abbotts Cholesterol Drug Trilipix

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FDA approves an Abbott NDA for its cholesterol drug Trilipix.

Comments Sought on DTC Coupons

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Federal Register Notice: FDA seeks comments on the impact of coupons in DTC print ads on consumers perceptions of products risks a...

FDA Approves Eisais Lusedra

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FDA approves Eisais Lusedra for monitored anesthesia care in adults undergoing diagnostic or therapeutic procedures.

Onsolis NDA Resubmitted with REMS

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BioDelivery Sciences says it has resubmitted its Onsolis NDA with a REMS as requested by FDA in its complete response letter.

Grassley Raises Medical Ghostwriting Questions

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Sen. Chuck Grassley asks Wyeth and DesignWrite for information on their medical ghostwriting activities involving hormone therapy ...

New Report on Refining HHS Also Addresses FDA Fixes

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FDA commissioners as well as other HHS agency heads should be appointed based on their experience and leadership skills, without r...