Information by Drug Class > Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)

Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)

FDA Holds Advisory Committee Meeting on Its Proposal for a Class REMS for Certain Opioid Drugs (Update - September 2010)
On July 22 and 23, 2010, FDA presented its proposal for a class REMS for long-acting (LA) and extended-release (ER) opioid drugs at a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The objective of the meeting was to gather additional feedback and comments from the Committees and the public on its proposal to require a REMS for the class of long-acting and extended-release opioid products.

FDA is currently analyzing the advice received from the Committees and from public comments. Once these have been thoroughly analyzed, FDA may issue a REMS request letter to the appropriate sponsors. The letter would describe the proposed REMS and provide a timetable for the submission of the REMS and its implementation. Affected sponsors would be required to implement the REMS, once it is approved.

Readers who wish may read the summary minutes or transcript of the meeting.

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Information by Drug Class > Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)