Search Results for: FDA

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 >

Opana ER: What other questions could have been asked?

PA experts observing the recent marketing withdrawal of Opana ER (oxymorphone hydrochloride) considered other data that could be examined to determine if there is something inherent to the formulation that encourages more dangerous avenues of abuse, and the impact of other external factors on real-world safety. On July 6, Endo Pharmaceuticals announced it would withdraw... Read more »... Read More >

Medicinal Cannabis: Lessons for Scheduling and FDA’s Expectations for Respiratory Drug Delivery

Development of cannabinoid-based medicines is a rapidly growing area of interest for patients with unmet needs as well as the pharmaceutical industry. The path forward, however, is fraught with technical and regulatory issues that require a thoughtful approach early and throughout the development process. At two recent medicinal cannabinoid conferences, CannMed 2017 and the 2017... Read more »... Read More >