Comment to the FDA: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction (Docket No. FDA-2019-N-2514)

Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates

These comments are submitted in response to the Federal Register notice Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction, Docket FDA-2019-N-2514. This is a written version of comments made orally at the September 17, 2019, Food and Drug Administration (FDA) public hearing on this topic.

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