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FDA OKs Intervet NADA for Cattle

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Federal Register Final rule: FDA approves an Intervet NADA for using zilpaterol to make medicated cattle feed.

FDA Approves Phibro sNADA

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Federal Register Final rule: FDA approves a Phibro Animal Health sNADA for revising labeling for oxytetracycline with the genus fo...

Court Nixes Boniva Advertising Injunction Request

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Proctor & Gamble loses a bid to get a preliminary injunction against advertising claims made by Roche and GSK for their osteoporos...

Public Meeting on Device Risk Communication

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Federal Register Notice: FDA and AdvaMed will sponsor a public meeting on risk communication on medical devices 9/26.

FDA Extends Review on Shire Colitis Drug

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FDA extends by 90 days its review of a Shire NDA for Mesavance.

Taro Files ANDA for Generic Trileptal

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Taro Pharmaceutical Industries submits an ANDA for a generic copy of Novartis seizure drug Trileptal.

Von Eschenbach Unlikely to Fix Deepening Crisis at FDA

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Washington commentator Robert Steeves reviews the likely impact on FDA of the latest Plan B legal depositions and the effectivenes...

Digene Taking HPV Ads National

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Digene expands its DTC campaign to educate women about HPV and its HPV test as part of cervical cancer prevention.

FDA Advisory on Concomitant Ibuprofen/Aspirin Use

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FDA issues a healthcare advisory on the concomitant use of ibuprofen and aspirin, which can render less effective aspirins cardiop...

Cooperation with FDA is Key Clinical Trial Need

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Consulting editor John Scharmann reports on an FDA-cosponsored clinical research in Minneapolis and concludes that sponsors need t...