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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.

Inspection Finds QS Issues at Health Science Products

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FDAs New Orleans District Office warns Health Science Products about repeat Quality System and Medical Device Reporting regulation...

FDA Approves Movantik for Opioid-induced Constipation

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FDA approves an AstraZeneca NDA for Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic...

FDA Corrects Notice on Lot Distribution Report Guidance

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Federal Register Notice: FDA corrects a notice on a draft guidance on electronic submission of lot distribution reports.

NY Law Chief Sues Actavis to Block Namenda Forced Switch

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New York attorney general Eric T. Schneiderman files an antitrust lawsuit seeking to block Actavis and subsidiary Forest Laborator...

Guidance on ANDA Refuse to Receive Due to Impurity Deficiencies

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CDER posts a draft guidance on ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits that highli...

84% Say CDRH Delivering Good Customer Service

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An ongoing CDRH customer survey finds that 84% of respondents are satisfied with the Centers customer service.