[ Price : $8.95]
Washington Legal Foundation makes several suggestions for changes to an FDA draft guidance on when to submit a new 510(k) for a ch...[ Price : $8.95]
Ophthotech says two Phase 3 studies evaluating its wet age-related macular degeneration drug Fovista (pegpleranib) failed to meet ...[ Price : $8.95]
MDMA says it disagrees with an FDA industry cost estimate in its draft guidance on information collecting for the unique device id...[ Price : $8.95]
FDA issues Alkem Laboratories a three-item Form-483 after an inspection recently concluded at the firms Ankleshwar, India active p...[ Price : $8.95]
Advocacy groups raise issues with a draft FDA guidance on evaluating appearance issues with advisory committee members.[ Price : $8.95]
Three Akin Gump attorneys review 21st Century Cures provisions affecting medical devices.[ Price : $8.95]
FDA says it has approved updated labeling for drugs containing pioglitazone covering additional studies showing a potentially incr...[ Price : $8.95]
FDA says it has speeded up the release of drug safety information on its Web site that houses labeling changes made post approval.