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Guilty Plea in Trial Falsification Case

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A Kansas doctor and clinical trial coordinator plead guilty to charges they falsified clinical trial data.

Drug Importation Amendment Added to FDA Spending Bill

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Sen. David Vitter (R-LA) introduces an amendment to allow personal importation of drug products from Canada during floor debate on...

Sanofi Reports Shortage with Insulin Product

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Sanofi and FDA report a temporary shortage of the company's Apidra SoloSTAR insulin pens due to a manufacturing problem in July.

Special Counsel Takes CDRH Whistleblowers Side

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The federal Office of Special Counsel takes the side of a CDRH biomedical engineer who blew the whistle on superiors who approved ...

Could Par Suit be 'Leverage' Attempt in Gov't Probe?

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FDA observer and attorney Arnie Friede says Par's recent First Amendment suit against the agency appears to be an attempt to gain ...

MDR Violations Found at Respironics

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FDAs Philadelphia District Office warns Respironics about Medical Device Reporting violations in its manufacturing of continuous v...

Post-marketing ADE Reporting Problems at Jazz

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FDAs San Francisco District Office warns Jazz Pharmaceuticals about adverse drug experience reporting violations.

FDA Clears Spineology Rampart Fusion Implants

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FDA clears a Spineology 510(k) for its Rampart Interbody fusion implants.

Quality Problems Found in SKB England Facility

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FDA warns SmithKline Beecham of CGMP problems at a UK drug manufacturing plant.

Republican Lawmakers Introduce 10 CDRH Reform Bills

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House Energy and Commerce Committee Republicans introduce 10 bills they say will improve predictability, consistency, and transpar...