The ESA APPRISE Oncology Program: A History of REMS Requirements, a Review of the Data, And an Approach to Compliance in the Hospital.

摘要

On September 27,2007, President George W. Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) program for drugs and biological agents. REMS programs are intended to support the safe use of products for which the risks and benefits need to be carefully weighed in general or in specific patient populations. The FDA can require a REMS program at the time of a product's approval. If a safety problem is detected after approval, the REMS can be required at any time during a drug's life cycle.