Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative S...
Federal Register notice FDA announces the fiscal year 2023 rates for the establishment and reinspection fees related to entities that compound human d...
Federal Register notice: FDA makes available a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers Patient Labeling Recommen...
Federal Register notice: FDA sets fee rates and payment procedures for fiscal year 2023 for animal drug user fees.
An AP report says FDA commissioner Robert Califf is facing skepticism that the agency will address the nations opioid crisis in a meaningful way.
FDA reviews the first-year accomplishments and future plans for the multi-country Generic Drug Cluster.
Researchers in the U.S. and Australia call for an update to transparency policies so that all individual participant data supporting oncology drug reg...
FDA sets 5/23/23 as the target PDUFA action date for its review of ImmunityBios N-803 to treat some bladder cancers.