FDA Issues Guidelines for Misuse-Deterrent Opioids
FDA has released final guidance on the development of brand-name, misuse-deterrent opioids. The new guidance explains the type of studies necessary to establish misuse deterrence, as well as how such studies should be conducted and evaluated. The guidance does not require that all new opioids contain misuse-deterrent mechanisms. Instead, new products will be reviewed on a case-by-case basis.
- "FDA Issues Final Guidance for Abuse-Deterrent Opioids" (Fiore, "Gupta Guide," MedPage Today, 4/1).