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Trade Talks Can Help Speed Drug Development: Article

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Lilly CEO John Lichleiter writes in Forbes that the U.S. and EU should use upcoming trade negotiations to take steps to ease drug ...

OIG Whitewashing HHS Impropriety: Public Citizen

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Public Citizens Michael Carome says Congress should make the HHS Office of Human Research Protection an independent agency so it w...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Advanced MicroVas II, Descor, Health Science Products, John W. Hollis Inc., dba ...

Three Groups Disagree on Biologic Names

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Three organizations differ in their comments to FDA on whether biologics should have unique nonproprietary names.

Acura Pharma Files Dispute Resolution Request on Vycavert

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Acura Pharmaceuticals files a formal dispute resolution request for Vycavert, an abuse-deterrent formulation of hydrocodone and ac...

FDA Withdraws Proposed Rule on Pulse Generator Devices

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Federal Register Proposed rule: FDA withdraws a proposed rule reclassifying the external pacemaker pulse generator devices.

Pulse Generator Devices into Class 2

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Federal Register Proposed order: FDA proposes to reclassify the external pacemaker pulse generator devices into Class 2.

FDA Accepts Tuzistra NDA for Cough/Cold

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FDA accepts for review a Vernalis and Tris Pharma NDA for Tuzistra XR (CCP-01), an extended-release liquid said to be equivalent t...

FDA Panel Narrowly Backs NPS Pharmas Natpara

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 8 to 5 that available data support approval of NPS Pharmaceutical...

DoJ Files Motion Against Bayer and its Dietary Supplement Marketing

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The Department of Justice files a motion seeking to hold Bayer in contempt for violating a 2007 court order prohibiting it from ma...