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FDA publishes a guidance on using real-world data and evidence to support drug and biological product regulatory decision-making.[ Price : $8.95]
FibroGen says its Phase 3 LELANTOS-2 trial of pamrevlumab for treating ambulatory patients with Duchenne muscular dystrophy did no...[ Price : $8.95]
Hamilton Medical recalls its Hamilton-C1, C2, C3, and T1 ventilators after receiving reports about software issues that may cause ...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Extralabel Drug Use in Animals -- 21 C...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Dispute Resolution Procedures for Scie...[ Price : $8.95]
FDA publishes a guidance to assist drug supply chain stakeholders to meet the requirements for enhanced drug distribution security...[ Price : $8.95]
FDA issues two compliance guidances to implement a one-year stabilization period giving trading partners additional time to meet D...[ Price : $8.95]
Five stakeholders respond to FDA docket questions about expanding home medical technology use.