FDA publishes a white paper on the assessment approach to be used as part of CDERs Quality Management Maturity program.
FDA commissioner Robert Califf says much remains to be done to combat the changing opioid crisis in the U.S.
FDA publishes a guidance on using real-world data and evidence to support drug and biological product regulatory decision-making.
FibroGen says its Phase 3 LELANTOS-2 trial of pamrevlumab for treating ambulatory patients with Duchenne muscular dystrophy did not meet the primary e...
Hamilton Medical recalls its Hamilton-C1, C2, C3, and T1 ventilators after receiving reports about software issues that may cause the devices to stop ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Extralabel Drug Use in Animals -- 21 CFR 530.
Federal Register notice: FDA seeks comments on an information collection extension entitled Dispute Resolution Procedures for Science-Based Decisions ...
FDA publishes a guidance to assist drug supply chain stakeholders to meet the requirements for enhanced drug distribution security at the package leve...
