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Clinical Investigator Training Course Planned

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Federal Register Notice: FDAs Office of Critical Path Program and the Clinical Trials Transformation Initiative will hold a traini...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Boca Pharmacal, CeraSys, IriSys, Steril-Aire, and Terry Yon & Assoc. dba TYA Pha...

CGMP Problems Found at InSys Facility

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FDAs Los Angeles District Office warns InSys of CGMP violations in its manufacturing of an unapproved new drug.

Congress Opens Discussion on Major FDA Changes

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House Energy and Commerce Committee Democratic leaders have released a draft of legislation to strengthen FDAs authority and fundi...

AstraZeneca Seeks $500 Million Budget Boost for FDA

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AstraZeneca urges the Obama Administration to boost FDA's funding by 20% when it proposes the agency's fiscal year 2012 budget in ...

Justice Department Intervenes in Rapamune Off-label Suit

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A Philadelphia federal court grants a Justice Department motion to intervene in a whistleblower suit involving Pfizer's organ tran...

FDA Requests Safety Meeting on AMAG Pharma's Feraheme

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FDA asks AMAG Pharmaceuticals to meet with drug safety officials to discuss a potential safety issue involving the company's Ferah...

Sharfstein Asked to Testify at House J&J Hearing

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The House Oversight and Government Reform Committee asks FDA principal deputy commissioner Joshua Sharfstein to testify at a 9/30 ...

Marketing Can Lower Drug Costs: Ehrlich

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Drug marketing gurus Bob Ehrlich and John Mack debate the state of DTC marketing in an Internet radio broadcast.

Panel to Discuss Aranesp Study

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 10/8 to discuss the TREAT study of Amgen...