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FDA Six-month Review on Biovails Bupropion

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FDA assigns a six-month review to Biovails recently submitted complete response to its not approvable letter received in July on B...

Info on Animal Drug User Fees Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the animal drug user fee cover sheet to the Office of...

FDA Approves Avalide sNDA

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FDA approves a sNDA for Sanofi-Aventis and Bristol-Myers Squibbs fixed dose combination antihypertensive Avalide.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites All Medicus and Ben Venue Laboratories.

FDA Safety Alert on Pfizers Chantix

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FDA says it is reviewing postmarketing safety reports from Pfizer on its smoking cessation drug Chantix, including reports of suic...

Barr Submits ANDA for Generic Focalin

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Barr Pharmaceuticals submits an ANDA for a generic copy of Novartis Focalin XR.

Move Against Office of Internal Affairs Not Enough, He Says

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A former victim of CDRH enforcement abuse says the recent revocation of FDA Office of Internal Affairs authority in favor of the H...

Guidance on Advisory Panel Voting Procedures

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Federal Register Notice: FDA releases a draft guidance on voting procedures for advisory committee meetings.

Info on Cooperative Biologic Mfg. Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a guidance for cooperative manufacturing arrangements f...