The Regulatory Environment for Pain and Addiction Therapies

4:30 PM - 5:30 PM, Tuesday, June 4,2019 ・ 106AB, Level 100
Over the course of 2018 and 2019, the Food and Drug Administration (FDA) has proposed and implemented several regulatory changes that impact the development and review of novel pain and addiction therapies. Such changes include the development of draft guidance on developing endpoints for demonstrating effectiveness for medication assisted treatments, advisory committee meetings on opioid sparing. Additionally, in 2018 Congress passed the SUPPORT for Patients and Communities Act which required the FDA to hold public meetings and develop or update guidance on several topics pertaining to the development and review of new pain and addiction therapies. During this panel discussion, panelists will review regulatory changes promoting the development of novel and safer therapies, additional regulatory changes that we might expect to see in 2019, and other potential changes that may aid in the development of novel and safer pain and addiction therapies in the future.
Moderator
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Vice President, Pharmaceutical Risk Management Services
Pinney Associates, Inc
Speakers
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Vice President, Pharmaceutical Risk Management Services
Pinney Associates, Inc
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President and Chief Executive Officer
Amygdala Neurosciences
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Chief Regulatory Officer
Flexion Therapeutics