FDA Guidance
Legislative documents and FDA guidance documents regarding REMS
February 2011
Guidance for Industry
Medication Guides - Distribution and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)
September 2009
Guidance for Industry
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications
July 2009
Guidance for Industry
Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act
June 2009
Guidance for Industry
Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events
March 2008
Federal Register Deemed REMS Notice
Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007
September 2007
Food and Drug Administration Amendments Act of 2007
