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Novartis Faces Anti-kickback Charges in Whistleblower Suit

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U.S. federal judge Paul Gardephe denies a Novartis motion to dismiss anti-kickback claims in a whistleblower suit originally filed...

FDA Seeks Injunction Against Pharmaceutical Innovations

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FDA seeks a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manuf...

Info on E-Records/Signatures Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on electronic record and signatures to the Office of Man...

Guidance on Laboratory Developed Test Oversight

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Federal Register Notice: FDA releases a draft guidance Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).

Panel to Discuss Vertex Pharma sNDA for Cystic Fibrosis

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 10/21 to discuss a Vertex Pharmaceuticals sNDA ...

Panel to Discuss Epidural Steroid Injections

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Federal Register Notice: FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet 11/24-25 to discuss risks with e...

FDA Advancing Biomarker Science in Drug Development

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FDA identifies several opportunities to advance biomarker science for product development.

Dallas Judge Cuts Transvaginal Mesh Award in Half

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A Dallas, TX judge slashes a jury award of $73 million to a woman who said she was injured by a Boston Scientific Corp transvagina...

Guidance on Laboratory Developed Test Notification and Reporting

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Federal Register Notice: FDA releases a draft guidance: FDA Notification and Medical Device Reporting for Laboratory Developed Tes...

Durata Therapeutics Gets Special Protocol Agreement in Pneumonia Trial

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FDA grants Durata Therapeutics a Special Protocol Agreement on the design of the companys Phase 3 study of Dalvance IV 1500 mg in ...