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FDA Approves Folate-containing OC by Bayer

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FDA approves a Bayer HealthCare combination oral contraceptive containing a folate to counter neural tube defects in developing fe...

CVM Workshop to Provide Electronic Submission Tool

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Federal Register Notice: FDA plans a public workshop 10/21 to provide access to the animal health industry CVMs electronic submiss...

FDA Reiterates Dental Handpiece Burn Alert

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FDA says it continues to be concerned about the potential for patient burns due to overheating dental handpieces.

Amgen Recalls Epogen and Procrit Lots Over Glass Particulates

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Amgen recalls certain lots of its anemia therapies Epogen and Procrit (epoetin alfa) vials due to the potential for the products t...

House Passes Clinical Trials Bill

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The House approves legislation removing a financial barrier to participating in clinical trials.The House approves legislation rem...

Novartis Sues Over Famvir ANDA Approval

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Novartis sues to block FDAs approval of Watsons ANDA for generic Famvir in a split-certification case.

House Passes Bill to Ban Execs Involved in Medicare Fraud

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The House passes H.R. 6130 Strengthening Medicare Anti-Fraud Measures Act that would ban corporate executives from doing business ...

'Orphan' Status for Lymphoma Drug

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FDA grants an orphan drug designation to ZioPharm Oncology, Inc. for Zinapar (darinaparsin) for treating peripheral T-cell Lymphom...

Avandia Stays on the Market Under Restrictions

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FDA says GlaxoSmithKlines Avandia can remain on the market but the company must develop a REMS that sharply restricts its use to c...

Guidance on IVDs for H. pylori

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Federal Register Notice: FDA releases a draft guidance on 510(k) submissions for various types of in vitro diagnostic devices indi...