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Senate HELP Committee Approves Von Es Nomination

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The Senate HELP Committee approves Andrew von Eshenbachs nomination to be the next FDA commissioner, but two senators holds contin...

Vernalis Files Menstrual Migraine Drug

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FDA accepts a Vernalis supplemental NDA for Frova 2.5 mg tablets for short-term prevention of menstrual migraine.

Guidance on Changes Being Effected Supplements

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Federal Register Notice: FDA releases a draft guidance on releasing to the public labeling changes submitted in a Changes Being Ef...

Review Period Set for Mycamine

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Federal Register Notice: FDA determines the regulatory review period for Astellas Pharmas Mycamine for the purpose of patent exten...

Rx Importation Affecting Homeland Security Bill

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Republican congressional leaders are trying to put down a rank-and-file move to insert drug import legislation in homeland securit...

FDA Drug Seizures Hurt Nevadas Import Program

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A Vancouver pharmacist says U.S. government seizures of drugs mailed to Nevada consumers are hurting that states Rx imports progra...

FDA to Post Proposed Labeling Changes

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FDA says drug and biologic labeling revisions will now first be posted on the FDA Web site and DailyMed before agency review and a...

Special Controls for Hepatitis A Assay

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FDA issues a special controls guidance for hepatitis A virus serological assays.

Waxman Introducing Generic Biologics Pathway Bill

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U.S. Representative Henry Waxman (D-CA) tells generic drug manufacturers that he is putting the finishing touches on a bill that w...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Biolase Technology.