FDA publishes a draft ICH guidance on biopharmaceutics classification system-based biowaivers.
Federal Register notice: FDA makes available a guidance entitled Testicular Toxicity: Evaluation During Drug Development.
Federal Register notice: FDA makes available a draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Presc...
FDA commissioner Scott Gottlieb says the agency gained new authorities under the SUPPORT bill to combat the nations opioid crisis.
CDRH posts information about its planned Accreditation Scheme for Conformity Assessment pilot program to accredit testing laboratories.
FDA issues a revised safety alert on Alcons CyPass Micro-Stent due to its risk of eye damage.
FDA clears a Masimo 510(k) for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry that is intended to provide ...
Federal Register notice: FDA awards a priority review voucher to Leadiant Bioscience after determining that rare disease drug Revcovi (elapegademase-l...