Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access

November 8, 2017 – To manage the risks associated with drugs, the FDA employs a range of tools. For drugs that are associated with serious risks, the FDA can require drug makers to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. REMS can contain a variety of tools – such as a Medication Guide or patient package insert with information specifically written for patients, a communication plan, and … (leggi tutto)