About one in eight approval actions taken since FDA Amendments Act (FDAAA) provisions on drug safety went into effect in March contain a Risk Evaluation and Mitigation Strategy (REMS), FDA associate director for drug policy Jane Axelrad told a Regulatory Affairs Professionals Society meeting in Boston. She said standardized REMS could involve a single document containing the important requirements. The REMS supporting documentation that includes justifications for requiring the risk strategy would be in a separate document.
I in 8 approval actions call for REMS James G Dickinson Medical Marketing and Media; Nov 2008; 43, 11; Docstoc pg. 17 Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
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