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Some Whistleblower Records Properly Withheld: Court

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A DC federal court rules that HHS acted properly in redacting and withholding some documents sought by CDRH whistleblowers.

Academic Groups Air Biosimilar Patent Concern

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Leaders of six higher education associations ask FDA for a requirement that biosimilar applicants certify their compliance with th...

Reviewers Say Dynavax Hep B Vaccine is Effective

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CBER clinical reviewers tell the Vaccines and Related Biological Products Advisory Committee that Dynavax Technologies Heplisav ap...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites The Avalon Effect, Health Breakthroughs, I. Shay Cosmetics, Mushroon Wisdom, and...

Mixed Vote on Merck OTC Overactive Bladder Patch

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FDAs Nonprescription Drugs Advisory Committee delivers a mixed vote for a Merck proposal to market an over-the counter version of ...

NECC Sister Company Slapped With 20-page FDA-483

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FDA gives the sister company of troubled drug compounder New England Compounding Center a 20-page FDA-483 after a month-long inspe...

FDA Approves Watsons Generic Revatio

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FDA approves a Watson Laboratories ANDA for a generic copy of Pfizers Revatio.

Abbott Moves Promising Hep C Triple Combination Into Phase 3

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Abbott says it is moving into a Phase 3 trial a triple combination of investigational antiviral drugs for treating hepatitis C (HC...

FDA Approves IntelliCell BioSciences New Tissue Facility

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FDA approves the registration of IntelliCell BioSciences new facility in New York, NY to recover, process, package, store, and lab...

FDA Fast Track for Mesothelioma Drug

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FDA grants Morphotek orphan drug status for its investigational cancer drug, amatuximab, for treating malignant pleural mesothelio...