Posted by Michael Wonder on 08 Nov 2017
Statement from FDA Commissioner Scott Gottlieb on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
8 November 2017 - New FDA draft guidance to streamline the submission and review process for shared system REMS.
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 various “Elements to Ensure Safe Use” (ETASU). These elements may include requirements for prescriber training or patient counselling. These safety strategies are critical tools for the FDA to protect patient safety, which is why we want to help manufacturers apply these programs correctly, consistently, and efficiently.
