FDA announces review of opioid approval process
The Pharmaceutical Journal
November 6th, 2018

The US Food and Drug Administration (FDA) has said it will review its approach to approvals of new opioid analgesics in light of the ongoing opioid crisis in the United States.

In a statement, Scott Gottlieb, commissioner of the FDA, said it was "re-evaluating how we consider both the individual and public health impacts of new opioids as they are reviewed for approval".

In October 2018, the US government granted the FDA new authority to require studies evaluating the efficacy of opioids; the ability to require opioids to be sold in special packaging that allows the drugs to be safely disposed; and new powers to issue a mandatory recall order for any controlled substance.

The latest FDA press announcement, issued on 2 November 2018, followed its controversial approval of Dsuvia, a sublingual formulation of the extremely potent synthetic opioid sufentanil.
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