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The contingency legislation is needed in order for the Medicines and Healthcare products Regulatory Agency to take on regulatory processes that are currently undertaken by the European Medicines Agency and other bodies. Read More
Scilex Pharmaceuticals urged the FDA to remove unapproved lidocaine patches from the market and issue guidance on the marketing of such products. Read More
The agency is “taking new steps to help ensure that a product’s labeling provides actionable and complete information about the clinical evidence supporting an accelerated approval,” Commissioner Gottlieb said. Read More
The agency plans to issue guidance clarifying how the accelerated approval pathway may be used when a gene therapy targets a serious disorder not addressed by available therapy. Read More
Sponsors can use postmarket adverse event data, drug use data, and observational or epidemiological data, in addition to stakeholder input for their REMS assessments, the agency said. Read More