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Regulatory Focus™ > News Articles > Assessing Patient Understanding of Medication Guides

Assessing Patient Understanding of Medication Guides

Posted 01 October 2010

The passage of the Food And Drug Administration Amendments Act of 2007 (FDAAA) modified the Food, Drug, and Cosmetic Act and, specifically, created Section 505-1 to give FDA the authority to require Risk Evaluation and Mitigation Strategies (REMS) for certain drugs and biologics. The purpose of a REMS is to ensure that a drug's benefits outweigh its risks. A common element of all REMS is periodic assessment of the effectiveness of the strategy. FDAAA specifies assessments at 18 months and three years after approval of the REMS, and also in the seventh year.


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