Advocacy Issue: Risk Evaluation and Mitigation Strategy (REMS)

Recent Activity

FDA Announces Final REMS for Extended-Release and Long-Acting Opioids July 11, 2012

President Signs PDUFA Legislation into Law  July 11, 2012

 FDA Seeks Comment on Revised Application Review Program July 11, 2012

Feedback Request: FDA Developing Guidance on REMS Assessments  June 13, 2012

FDA Announces Public Workshop on REMS Assessments  May 16, 2012

Senate Prescription Drug User Fee Act Mark-Up  May 2, 2012

FDA Sends Congress User Fee Recommendations  January 25, 2012

APhA Comments to FDA on Draft Opioid REMS CE Blueprint  December 14, 2011

FDA Announces Draft Blueprint for Opioid REMS Prescriber Education November 16, 2011

FDA PDUFA V Update November 2, 2011

FDA Releases PDUFA V Agreement  September 7, 2011

APhA Articles

FDA approves final opioid REMS  July 17, 2012

Congress sends PDUFA V to Obama  June 28, 2012

REMS improvements proposed for PDUFA V in 2012  November 1, 2011

APhA releases second REMS white paper  May 16, 2011

APhA Resources
Agency Sources