Search Results for: FDA

Assessing Abuse Potential of Cannabinoids: Lessons Learned from Past CNS-Active Drug Development

Jack Henningfield, Reginald Fant and Daniel Wang The confusing and conflicting legal status of cannabis and its active constituents can inhibit product development as companies encounter significant and unique barriers to approval and appropriate scheduling. In a complementary webinar, Jack Henningfield, Ph.D., and Daniel Wang described how the development and regulatory submission of other CNS-active... Read more »... Read More >

Successful Rx to OTC Switch Depends on Responsiveness to FDA and Other Stakeholder Issues of Concern, Early and Integrated Commercial Planning

Christine Sweeney and George Quesnelle FDA approval of an Rx-to-OTC switch depend on anticipation of issues likely to be raised by FDA division and nonprescription staff, as well as other policy stakeholders.  Commercial success following approval similarly requires addressing issues even before submission and looking beyond FDA approval. “Rx-to-OTC switch is not a regulatory check-box... Read more »... Read More >

Behind the Scenes at Closed Sessions of FDA Advisory Committee Meetings for Abuse-Deterrent Opioids

Edward Cone, PhD – PinneyAssociates Chris Miller, MS – 3D Communications Communicating the public health benefit of abuse-deterrent formulations (ADFs) of opioids at a Food and Drug Administration (FDA) advisory committee (ADCOM) meeting presents complexities for Sponsors of these products. One of the key challenges Sponsors face is knowing what and how to effectively communicate... Read more »... Read More >

FDA Workshop on Abuse Deterrent Opioids: Distinguishing Products in Postmarketing Surveillance to Support Category 4 Labeling

Understanding the real-world effectiveness and value of abuse-deterrent opioids depends on surveillance designed to evaluate how these formulations work in the real world, product by product, and distinguishing prescription opioids from illicitly produced street products, such as counterfeit synthetics. Drs. Sid Schnoll and Jack Henningfield both reinforced this message in a public workshop organized by... Read more »... Read More >