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...
FDA issues two compliance guidances to implement a one-year stabilization period giving trading partners additional time to meet Drug Supply Chain Sec...
Five stakeholders respond to FDA docket questions about expanding home medical technology use.
