Federal Register notice: FDA makes available a final guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety a...
Federal Register notice: FDA makes available a final guidance entitled General Considerations for Animal Studies Intended to Evaluate Medical Devices....
The chair and ranking member of the House Energy and Commerce Health subcommittee ask CBER director Peter Marks for detailed information on FDA clinic...
Four U.S. Representatives introduce the Biologics Competition Act, a bipartisan bill that would order HHS to evaluate the process by which interchange...
GSK says it plans to submit a BLA supplement by 7/1 after reporting interim results from a Phase 3 trial investigating Jemperli (dostarlimab) plus sta...
FDA approves changes to labeling for two Hedgehog inhibitors covering musculoskeletal adverse reactions and creatine kinase monitoring as requested in...
FDA publishes a final guidance entitled General Considerations for Animal Studies Intended to Evaluate Medical Devices.
BrainStorm Cell Therapeutics says it has refiled a BLA under the agencys file-over-protest procedure for NurOwn, a stem cell therapy for treating amyo...
