FDA explains its biomarker qualification context of use statement.
Federal Register notice: FDA announces fiscal year 2018 rates for generic drug user fees.
FDA releases its latest batch of Warning Letters that includes Hetero Labs Limited and Total Nutrition.
FDA clears a Leica Microsystems 510(k) for its FL560 fluorescence microscope filter for visualizing cerebrovascular blood flow in conjunction with the...
FDA grants UroGen Pharma a fast track designation for MitoGel and its use in treating patients with low-grade upper tract urothelial carcinoma.
CDRH Office of In Vitro Diagnostic Device Evaluation and Safety director Alberto Gutierrez announces his retirement.
Federal Register notice: FDA announces a 10/12 Cellular, Tissue, and Gene Therapies Advisory Committee meeting.
CDRH sends out a letter to medical device establishments to provide information about device user fees, including fee rates and payment procedures, fo...