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AdvaMed and other industry groups comment on FDAs recent draft guidance on The Special 510(k) Program, suggesting that the documen...[ Price : $8.95]
FDA approves a Medifocus PMA supplement for new labeling for its Prolieve Transurethral ThermoDilatation Therapy based on the resu...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled: Oversight of Clinical Investigations:...[ Price : $8.95]
A New England Journal of Medicine online perspective reviews the success on FDAs Sentinel medical product safety system that was l...[ Price : $8.95]
CDER posts a Manual of Policies and Procedures to update policy on Drug Shortage Management.[ Price : $8.95]
FDA clears a Meridian Bioscience de novo submission for a new diagnostic test to aid in detecting a type of herpes virus called cy...[ Price : $8.95]
A new Government Accountability Office report recommends that FDA ensure that information from orphan drug designation application...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Blood Glucose Monitoring Test Systems for Prescription Poin...