FDA still considering labeling change
"FDA has not yet resolved the issues raised in your citizen petition dated July 25, 2012," said a letter from the Food and Drug Administration.
It came in response to a proposal to relabel opioid medications from "moderate to severe" pain to "severe" pain. "FDA has been unable to reach a decision on your petition because it raises significant issues requiring extensive review and analysis by Agency officials. This interim response is provided in accordance with FDA regulations ... we will respond to your petition as soon as we have reached a decision on your request."
July 15, 2013
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