Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting; Reopening of Comment Period

Streszczenie

The Food and Drug Administration (FDA) is reopening until October 19, 2010, the comment period for the notice of public meeting published in the Federal Register of April 20, 2009 (74 FR 17967). In that notice, FDA announced a public meeting that took place on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. FDA is reopening the comment period in light of continued public interest in this topic and to provide an opportunity for all interested parties to provide information and share views on the matter.