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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Biotivia America, Cytosol Laboratories, EXACT Sciences, Efficas, Health MarketPl...

Panel to Discuss Abbot Vascular and Thoratec PMAs

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 11/29-30 to discuss Abbott Vasculars Xience V Everolimus ...

FDA OKs Elanco sNADA

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Federal Register Final rule: FDA approves an Elanco Animal Health sNADA for increased monensin in cattle feed containing ractopami...

FDA Rejects Sandoz ANDA for Generic Lovenox

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FDA sends Sandoz a not approvable letter on an ANDA for a generic copy of Sanofi-Aventis Lovenox (enoxaparin sodium) for injection...

Stop Work on Reagan-Udall: DeLauro

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Rep. Rosa DeLauro asks FDA to stop work on the Reagan-Udall Foundation and explain how it will not place too much industry influen...

CGMP Violations at Cytosol Laboratories

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FDAs New England District Office again finds CGMP violations at Cytosol Laboratories.

Regulatory Problems with Exact Science Assay

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FDA says Exact Sciences PreGen-Plus colorectal screening assay is being marketed without an FDA approval or clearance.

Amitiza DTC Campaign Launched

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Takeda launches a DTC campaign to encourage constipation sufferers to Move to Amitiza.

Import Plan to Rely on Product Certifications

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A new Bush administration import safety plan recommends giving FDA the authority to require a certification from foreign governmen...

Bill Would Ratchet-up FDA Enforcement on OTC Drugs

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Senators Kennedy and Waxman introduce legislation to give FDA authority to remove unsafe over-the-counter (OTC) drug products with...