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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 ...

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...

Temple Sees No Conflicts in Marketed Drug Safety Reviews

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CDER deputy director for clinical science Bob Temple says during a television interview that there is nothing wrong with a drug re...

Avastin sBLA Review Extended

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Information submitted to FDA in a Genentech supplemental BLA for Avastin is deemed a major amendment by FDA and therefore the revi...

FDA Sets Biosimilars Meeting

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FDA reportedly will hold a two-day public hearing on issues and challenges associated with implementing a regulatory pathway for f...

FDA Approves Medtronic Integrity Stent System

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FDA approves a Medtronic PMA for its continuous sinusoid technology Integrity Coronary Stent System.