FDA publishes a draft guidance with recommendations for 510(k) submissions for orthopedic non-spinal bone plate, screw, and washer devices.
The DC federal court orders FDA to give Vanda Pharmaceuticals information from its review of a Vanda sNDA for a new Hetlioz indication.
FDA warns Dallas, TX-based Cornea Associates about conducting clinical investigations without submitting a required IND.
Merck says it will meet with regulatory authorities about an expanded indication after reporting Phase 3 trial results of Keytruda in certain endometr...
The leadership of the House Energy and Commerce Committee and two of its subcommittees asks FDA for detailed drug shortage information about 10 specif...
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...