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FDA Updates NECC Consignee List

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FDA posts a corrected and updated list of New England Compounding Center customers who received product on or after 5/21.

Track and Trace Discussion Draft Floated on Hill

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House and Senate leaders float a pharmaceutical track and trace discussion draft that would require FDA to publish track and trace...

Amneal Wants Suboxone Petition Denied

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Amneal asks FDA to deny a Reckitt Benckiser petition seeking to require specific actions by companies pursuing ANDAs for generic S...

2 CDER Clinical Consultative MAPPs Issued

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CDER issues MAPPs on clinical consultative procedures for drugs regulated by the Office of New Drugs and for cancer drugs.

FDA Grants Priority Review to Ariad NDA for Leukemia

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FDA accepts an Ariad Pharmaceuticals NDA for accelerated and priority review for ponatinib for patients with chronic myeloid leuke...

Bayer Phase 3 Trial Meets Primary Endpoint in Pulmonary Hypertension

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Bayer HealthCare says the CHEST-1 Phase 3 trial met its primary endpoint in evaluating riociguat in patients with pulmonary hypert...

FDA Rejects United Therapeutics NDA

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FDA sends United Therapeutics a complete response letter declining to approve its oral treprostinil for treating pulmonary arteria...

FDA OKs SpineSmith VisuALIF Challenging Access Plate System

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FDA approves SpineSmiths VisuALIF Challenging Access Plate System, an extension to its anterior lumbar interbody fusion device to ...

Temple Examines Predictive Enrichment in Clinical Trials

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CDER deputy center director for clinical science Robert Temple examines predictive enrichment in clinical trials that will be cove...

Minimize Collection of Non-essential Data: Novartis

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Companies commenting on FDA data standards urge the agency to be consistent in standards and their application.