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Methadone Supply Issues Resolved

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FDA says Xanodyne has resolved methadone HCl supply issues.

BIO Wants Reviewers in on EOP2A Meetings

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BIO and Merck recommend changes to clarify and improve FDAs draft guidance on End-of-Phase-2 meetings.

Questcor Resubmits sNDA for H.P. Acthar Gel

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Questcor Pharmaceuticals resubmits a supplemental NDA seeking approval to market its H.P. Acthar Gel for treating infantile spasms...

Repeat CGMP Deviations at Caraco Facility

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In a just-released Warning Letter, FDAs Detroit District Office cites fast-rising generic drug maker Caraco for significant repeat...

ViroPharam sBLA for Cinryze Therapy

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ViroPharma submits a supplemental BLA for Cinryze C1 Inhibitor (human) seeking approval as a treatment for acute hereditary angioe...

ESA Medication Guide Q&A

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CDER issues a question-and-answer document on Medication Guides for Procrit, Epogen, and Aranesp.

FDA Orders New Innohep MortalityWarning

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FDA orders Pharmion to revise Innoheps labeling to reflect an interim finding from a study, stopped in February, of an increase i...

Bayer Signs Corporate Integrity Agreement with HHS

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Bayer agrees to a $97.5 million payment and a corporate integrity agreement to resolve false claim allegations on consumer diabeti...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Actelion Pharmaceuticals, Caraco Pharmaceutical, RHG & Co., Stratec Medizintechn...

QS Problems at German Device Firm

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CDRH warns Stratec Medizintechnik about QS problems at its bone densitometer manufacturing facility in Germany.