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Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry ...[ Price : $8.95]
An International Consortium of Investigative Journalists report finds that unlike CDER, CDRH refuses to make public MAUDE data on ...[ Price : $8.95]
FDA authorizes Roche to market its cobas vivoDX MRSA diagnostic test that speeds the detection of MRSA using new technology.[ Price : $8.95]
CBER says Chara Biologics is marketing its CharaCore cell product to treat serious diseases and conditions without agency approval...[ Price : $8.95]
FDA approves three ANDAs for the first generics of Novartis Gilenya (fingolimod) capsules for treating relapsing forms of multiple...[ Price : $8.95]
FDA launches its CURE ID Internet-based repository for reporting experiences using approved drugs in new ways to treat hard-to-tre...[ Price : $8.95]
Genus calls on FDA to rescind its acceptance of a Lannett 505(b)(2) application for a cocaine hydrochloride product.[ Price : $8.95]
Several professional groups take issue with provisions in an FDA discussion paper on a benefit/risk approach for medical devices f...