The FDA reopened until October 19, 2010, the comment period of a public meeting held on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. The affected opioid drugs included long acting and extended release brand name and generic products that were formulated with the following active ingredients: fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA reopened the comment period in light of continued public interest in the topic and to provide an opportunity for all interested parties to provide information and share views on the matter. Interested persons were originally given until June 30, 2009, to comment.
SOURCE: FDA Notice
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