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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
The FDA issued revised guidance on electronic submissions of drug master files, extending the timetable for Type III submissions by another year to May 5, 2020. Read More
Competition is the key to lower drug costs, the Pharmaceutical Care Management Association (PCMA) said in a letter to lawmakers in defense of pharmacy benefit managers. Read More