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FDA publishes a draft guidance making recommendations on the design and analysis of drug development trials conducted under a master protocol.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FDA publishes a draft guidance on developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy...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.
FDA says it has seized thousands of units of counterfeit Ozempic that also contain counterfeit needles.
FDA commissioner Robert Califf says a new final rule allowing some waivers of informed consent will enable minimal-risk research that would not otherw...
FDA publishes a draft guidance revising a recent draft on quality considerations for topical ophthalmic drugs.
