Events & Ideas

The present document provides an 8-FA of 7-OH according to the 1970 Controlled Substances Act. This  has been developed following the model laid out in FDA’s guidance, Assessment of the Abuse Potential of Drugs, while also taking into consideration the experience and evolution in approach to such assessments since the CSA was signed into law… Read More

Broadly, we support the Food and Drug Administration adopting this Proposed Rule as part of FDA’s Comprehensive Plan for Nicotine and Tobacco Product Regulation. We believe it could lock in the encouraging gains as both youth and adult cigarette smoking have declined to historic lows while further accelerating these declines to the lowest possible levels…. Read More

Marion Coe, Director, Clinical Development and Postmarketing Surveillance at Pinney Associates I support approval of midomafetamine (MDMA) capsules for the treatment of posttraumatic stress disorder (PTSD). This medication assisted therapy holds significant potential for public health benefit by providing an effective treatment for PTSD, a condition affecting millions of people. It is likely to contribute… Read More

Jack Henningfield, Vice President, Research Health Policy and Abuse Liability, Pinney Associates. I support the approval of MDMA for the treatment of post-traumatic stress disorder (PTSD). Phase 2 and 3 studies have demonstrated efficacy and, equally importantly, the studies have shown that it can be used safely under various conditions and approaches to therapeutic use… Read More

Schnoll S, Beck R, Henningfield J, Ashworth J. The 2022 revision is a positive step forward in addressing the challenges that worsened the disparities in access to pain medicines that resulted from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain – United States. READ OUR COMMENT

Henningfield JE, Huestis MA, Grundmann O, Swogger MT, Prozialeck WC, Garcia-Romeu A, McCurdy CR. This is a collaborative comment of concerned scientists regarding the WHO ECDD report addressing the review status of kratom and its alkaloids. READ OUR COMMENT

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… Read More

Henningfield J.E., Grundmann, O., Babin, J., Laredo, G., and Cone, E.   View PDF