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Federal Register notice: FDA withdraws two proposed medical device rules after determining that they are not currently considered ...[ Price : $8.95]
The HHS Inspector General recommends ways FDA can improve its policies and procedures to address medical device postmarket cyberse...[ Price : $8.95]
FDA says it is evaluating over 75 reports of battery shutdown and other issues with Maquet/Datascope intra-aortic balloon pumps.[ Price : $8.95]
FDA clears an OsteoRemedies 510(k) for the Remedy Spectrum GV Hip Spacer System and Spectrum GV Bone Cement, which are intended to...[ Price : $8.95]
Heron Therapeutics files an NDA for HTX-011, a long-acting, extended-release formulation of the local anesthetic bupivacaine in a ...[ Price : $8.95]
CDRH director Jeffrey Shuren says current cell phone radiofrequency exposure limits are acceptable to protect the public health.[ Price : $8.95]
FDA outlines for the House Energy and Commerce Committee its staffing levels of Port of Entry special agents tasked with stopping ...[ Price : $8.95]
Former FDAer Peter Pitts praises agency efforts to speed approval of generic and branded drugs.