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Attorney and former FDA director of medical device compliance Larry R. Pilot petitions the agency asking that it begin the adminis...[ Price : $8.95]
MDMA says FDA should not use a draft guidance on 510(k) substantial equivalence decisions to reassess device classifications of pr...[ Price : $8.95]
Rutgers Biomedical and Health Sciences chancellor Brian Strom says an independent advisory committee he chairs encourages drug com...[ Price : $8.95]
FDA approves an Arbor Pharmaceuticals NDA for its Sotylize (sotalol hydrochloride) oral solution, indicated for treating documente...[ Price : $8.95]
An FDA workshop lays the groundwork for a proposed master protocol that the agency is spearheading to advance an international gen...[ Price : $8.95]
Reuters reports that the Department of Homeland Security is looking at two dozen medical devices that could be susceptible to cybe...[ Price : $8.95]
Federal Register Final Order: FDA classifies nucleic acid-based in vitro diagnostic devices for MTB-complex into Class 2.[ Price : $8.95]
Public Citizen says FDA should withdraw its 6/11 draft guidance on distributing scientific and medical publications because it wou...