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Role of Technology in Effective Implementation of REMS

Role of Technology in Effective Implementation of REMS

The Food and Drug Administration Amendments Act (FDAAA) of 2007 signed on September 27, 2007 authorizes the Food and Drug Administration (FDA) to require manufacturers to submit a proposed Risk Evaluation and Mitigation Strategy (REMS) if the FDA determines that REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks. The act took effect on March 25, 2008 and it applies to applications submitted under Food and Drug Cosmetics Act (FDCA) subsection 505 (b) or (j) and applications submitted under section 351 of the Public Health. These applications are termed covered applications and refer to new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologic license applications (BLAs).

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