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2 Pain Drug NDAs Head to Panel

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Cell/Tissue Product Registration Info Collection

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

CDRH, CDER Differ on Releasing Gender Info

[ Price : $8.95]

An International Consortium of Investigative Journalists report finds that unlike CDER, CDRH refuses to make public MAUDE data on ...

FDA Authorizes Roche MRSA Detection Test

[ Price : $8.95]

FDA authorizes Roche to market its cobas vivoDX MRSA diagnostic test that speeds the detection of MRSA using new technology.

Chara Biologics Markets Unapproved Cell Product: CBER

[ Price : $8.95]

CBER says Chara Biologics is marketing its CharaCore cell product to treat serious diseases and conditions without agency approval...

FDA Approves 3 ANDAs for Generic MS Drug

[ Price : $8.95]

FDA approves three ANDAs for the first generics of Novartis Gilenya (fingolimod) capsules for treating relapsing forms of multiple...