
FDA Launches New REMS Website
The agency streamlines risk and mitigation information.
FDA has launched its new Risk Evaluation and Mitigation Strategies (REMS) website. REMS controls were created as part of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which gave FDA the authority to require REMS from manufacturers so the agency could ensure that the benefits of a drug product outweigh the potential risks. A REMS creates a strategy for managing serious risks associated with a drug. FDA may require a REMS for approval of a new drug or when there is new safety information on an already approved drug.
The new
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.