REMS: A New Duty for Pharmacists?

摘要

There have been a number of articles in the past few months discussing REMS, an initiative of the FDA to control drug safety issues. REMS stands for Risk Evaluation and Mitigation Strategy and is intended to manage known or potential problems for drugs that present an especially important risk. NDA Options In the past, when the FDA received a new drug application (NDA) for approval, the FDA experts panel would review the drug safety and efficacy data collected by the manufacturer and either approve or deny the NDA. This up-or-down approach to voting could be very cosdy to manufacturers and innovators of new drugs and could prevent the marketing of drugs that have known adverse reactions but are still useful in treating specific conditions in certain circumstances.