Zdrowie i gospodarka · 01/10/2009

FDA Releases Draft Guidance on REMS Format and Content Requirements

The Food and Drug Administration (FDA) has released a draft guidance outlining the format and content requirements for proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and proposed REMS modifications. The guidance aims to clarify FDA's expectations for industry submissions, following the passage of the Food and Drug Administration Amendments Act of 2007.