FDA commissioner Robert Califf says the agency recently published three additional guidances to help advance the use of real-world data and real-world...
FDA publishes a guidance on assessing registries to support drug and biologic regulatory decision-making as part of its real-world evidence program.
FDA says ResMed has issued updated instructions for its masks with magnets to inform users about potential magnetic interference when magnets are near...
FDA publishes a guidance to assist sponsors in conducting efficient and successful drug development programs to treat rare diseases.
FDA publishes a draft guidance making recommendations on the design and analysis of drug development trials conducted under a master protocol.
FDA requires updated labeling for promethazine HCl injection to recommend administration through deep intramuscular rather than intravenous administra...
FDA publishes a draft guidance on developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy...
FDA warns Indias Patco Cosmetics about CGMP violations in its manufacturing of finished over-the-counter drugs.
