Risk Management
OSE leads the review of proposed and implemented risk evaluation and mitigation strategies (REMS). Once a medicine is on the market, it needs to be used in a way that ensures potential benefits outweigh potential risks. The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted FDA the authority to require the submission and implementation of a REMS if FDA determines a REMS is necessary to ensure that a drug's benefits outweigh its risks.
REMS components may include Medication Guides, patient package inserts, a communication plan for health care providers, elements to assure safe use including requirements for those who prescribe, dispense or use the drug and a timetable for submission of REMS assessments.
(See Approved Risk Evaluation and Mitigation Strategies (REMS) for a list of approved REMS.)
