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The Institute of Medicine posts a summary of a workshop held 7/28 as part of a FDA-requested assessment of the 510(k) process.[ Price : $8.95]
Wyoming federal judge Alan Johnson says FDAs actions in warning companies to stop manufacturing unapproved morphine sulfate soluti...[ Price : $8.95]
Researchers say FDA may need to provide decision-making tools to help healthcare professionals decide how a new warning on an exis...[ Price : $8.95]
Medical device entrepreneur Josh Makower says a survey of 200 medical device firms shows that FDA regulatory delays and inefficien...[ Price : $8.95]
FDA clears Bmeyes ccNexfin noninvasive cardiovascular monitor with blood pressure, cardiac output, and Masimo rainbow SET pulse co...[ Price : $8.95]
FDA approves a Prism Pharmaceuticals supplemental NDA for Nexterone (amiodarone HCl) Premixed Injection.[ Price : $8.95]
FDA's General and Plastic Surgery Devices Panel votes 8 to 7 that benefits outweighed risks for Mela Sciences PMA for MelaFind, in...[ Price : $8.95]
CDERs new program to mitigate threats to the drug supply chain starts small, without a budget, by determining its strategic plan, ...