Search Results for: Abuse Deterrent

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 >