Federal Register notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2022 $1,266,651.
Federal Register notice: FDA sets the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2022 $1,266...
FDA publishes a guidance on benefit/risk assessment in NDAs and BLAs.
Sidley says three former FDA attorneys have joined its Global Healthcare and FDA practice.
University of Chicago researchers say FDA should use a more data-driven approach to postmarket drug surveillance to avoid falsely determining that a d...
FDA clears NeuroWave Systems NeuroSENSE bilateral brain monitor to assess the adequacy of anesthesia and sedation in clinical settings.
FDA issues a warning about the potential risk of injury associated with the use of Max-Lux Corp.s Safe-T-Lite UV Wand because users and others may be...
FDA approves Mirums Livmarli to treat cholestatic pruritus in patients with Alagille syndrome age one and older.