lunedì, 20 marzo 2023
9 Novembre 2017

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)