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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...

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...

Lilly Stopping Edivoxetine Development

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Lilly says it is stopping development of edivoxetine as an add-on therapy for major depressive disorder.

Guidance on BE Recommendations on Paliperidone Palmitate

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Federal Register Notice: FDA releases a revised draft guidance: Bioequivalence Recommendations for Paliperidone Palmitate.

Maverick FDA Reviewer Marciniak on Broken Trial Process: BMJ

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Outspoken FDA reviewer Thomas Marciniak takes to the BMJ (formerly the British Medical Journal) to detail how the clinical trial p...

FDA External Affairs Chief Leaving Agency

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FDA associate commissioner for external affairs Virginia Cox leaves the agency next month to pursue other opportunities.

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...