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CDRHs Greg Campbell describes elements in the Centers final guidance on designing medical device pivotal clinical trials.[ Price : $8.95]
FDAs New York District Office warns Manhattan Reproductive Health about violations of regulations governing human cells, tissues, ...[ Price : $8.95]
FDA and CMS say they are extending for two years a Pilot Program for Parallel Review of Medical Products.[ Price : $8.95]
FDA denies a Public Citizen petition asking that it pull Rx and OTC orlistat from the market for safety reasons.[ Price : $8.95]
Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 1/14-16/14 to discuss Chelsea Therapeuti...[ Price : $8.95]
Federal Register Proposed rule: FDA proposes to amend a 1994 monograph to establish conditions under which OTC consumer antiseptic...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Stanislaw R. Burzynski, Burzynski Research Institute, Green Planet, Manhattan Re...[ Price : $8.95]
A just-released FDA proposed rule aims to require manufacturers of antibacterial hand soaps and body washes to demonstrate that th...