FDA says it has approved updated labeling for drugs containing pioglitazone covering additional studies showing a potentially increased risk for bladd...
Federal Register Notice: FDA determines that sodium chloride 23.4% in a plastic container (sodium chloride), injectable, 234 milligrams/milliliter was...
Federal Register Notice: FDA makes available a guidance entitled Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Heari...
Washington Legal Foundation makes several suggestions for changes to an FDA draft guidance on when to submit a new 510(k) for a change to an existing ...
Ophthotech says two Phase 3 studies evaluating its wet age-related macular degeneration drug Fovista (pegpleranib) failed to meet the pre-specified pr...
MDMA says it disagrees with an FDA industry cost estimate in its draft guidance on information collecting for the unique device identification system.
FDA issues Alkem Laboratories a three-item Form-483 after an inspection recently concluded at the firms Ankleshwar, India active pharmaceutical ingred...
Centurion begins a Class 1 recall of its Multi-Med Single Lumen Catheters due to excess material at the tip that may split or separate.