Generics Of Abuse-Deterrent Opioids Will Get FDA Guidance, Eventually

FDA is developing a step-wise approach for developers of generic versions of opioids with an abuse-deterrence claim, but first it needs the results of two research projects.

FDA is working on two ongoing research initiatives that will help it develop performance standards for generic formulations of abuse-deterrent opioids, in particular decision trees that will inform a step-wise approach that compares a generic to its reference-listed drug, Office of Generic Drugs Director, Division of Chemistry I, Andre Raw, said.

Once the agency feels the data from these initiatives are “sufficiently mature,” it intends to communicate the information via a...