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.
Magellan Diagnostics recalls its LeadCare II, LeadCare Plus, and LeadCare Ultra blood lead tests due to concerns about false low results.