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Magnetic Resonance Coil Performance Criteria Guide

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FDA posts a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Performance Based Pathway.

Amgens Remicade Biosimilar Gains Approval

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FDA approves an Amgen BLA for Avsola (infliximab-axxq), a biosimilar of Janssens Remicade, indicated for treating Crohns disease, ...

Increased Enforcement on Violative Cell/Tissue Products

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FDA steps up its enforcement efforts against violative cell/tissue products, and issues warnings against Liveyon Labs on the heels...

Physician Convicted in Insy Therapeutics Scheme

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A federal court convicts New York physician Gordon Freedman for participating in a scheme to receive bribes and kickbacks through ...

2 Pain Drug NDAs Head to Panel

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Federal Register notice: FDA announces a 1/15/2020 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety a...

FDA Seeking NDMA Testing

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FDA asks manufacturers of Zantac and Axid to test for NDMA impurities and not release lots that are above the acceptable daily lim...

Dietary Supplement GMPs Info Collection

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Federal Register notice: FDA is seeking comments on an information collection revision for Dietary Supplements good manufacturing ...

Cell/Tissue Product Registration Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension for Human Cells, Tissues, and Cellular and Tiss...

ViiV Files NDA for HIV Drug

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ViiV Healthcare files an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection...

Nonvoting Device Industry Reps for Panels Sought

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Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry ...