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FDA-483 Cites Biogen-Idecs Tysabri and Avonex Operations

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A just-posted FDA Form-483 cites Biogen-Idecs manufacturing and control operations involving the active pharmaceutical ingredients...

FDA Sees Some Benefit in Myalept, But Also Safety Concerns

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FDA says an Amylin Pharmaceuticals BLA for Myalept (metreleptin) has shown some benefit in a subgroup of patients suffering from l...

Gileads Solvaldi for Hep C Approved

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FDA approves a Gilead NDA for Sovaldi (sofosbuvir) to treat chronic hepatitis C virus infection.

Novartis Recalls Menveo Vaccine Due to Spec Deviation

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Novartis recalls one lot of its Menveo Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vacci...

Pacira Pharma Seeking OK for Additional Manufacturing Site

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Pacira Pharmaceuticals files a prior approval supplement seeking FDA approval for an additional bulk manufacturing suite for its p...

FDA Jilting Courts on First Amendment Ruling: WLF Counsel

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Washington Legal Foundation chief counsel Richard Samp writes that recent FDA enforcement actions point to it ignoring the First A...

FDA and China Reach Accord on APIs/Visas

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The U.S. and China reach an accord that has China committing to promote the reform of its regulatory system for active pharmaceuti...

FDA Approves First Penile Curvature Treatment

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FDA approves a new use for Auxilium Pharmaceuticals Xiaflex treating men with Peyronies disease that is characterized by a curvat...

Neutraceutical Importer Sues FDA Compliance Officer

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Neutraceutical importer H&M USA sues an FDA compliance officer over seizure of a shipment of acetaminophen active pharmaceutical i...

Companies Want UDI Database Guidance Clarified, Improved

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Medical device manufacturers and their trade association say there are inconsistencies between FDAs unique device identification f...