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Federal Register Notice: FDAs Medical Devices Dispute Resolution Panel will vote on a dispute between FDA and the Acorn Corp. on i...[ Price : $8.95]
House Committee on Energy and Commerce incoming chairman John Dingell (D-MI). says next Congress will examine issues involving Med...[ Price : $8.95]
CDER senior staff Federico Goodsaid calls for greater consensus on biomarkers, study protocols, and biological interpretations rel...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on Saline, Silicone Gel, and Alternative Breast Implants.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on designing clinical development programs for nonantimicrobial drugs to tr...[ Price : $8.95]
CDRHs Medical Devices Dispute Resolution Panel meets next month for the second time in nine years, to discuss scientific issues re...[ Price : $8.95]
The U.S. Court of Appeals for the District of Columbia agrees to rehear a case that found terminally ill patients should have acce...[ Price : $8.95]
A new FDA guidance says decorative contact lenses are subject to 510(k) or PMA clearance before they can be marketed.