FDA Finalizes Guidance On Studies Needed To Evaluate Generic ADFs

FDA published final guidance on Tuesday (Nov. 21) that lays out how the agency will evaluate generic abuse-deterrent formulations (ADFs) of oral opioids and includes recommendations of the types of studies sponsors should conduct to show the generic ADF is no less abuse-deterrent than its reference listed drug (RLD). The guidance is one part of FDA's efforts to advance “new policies to provide a more efficient pathway for the entry of generic opioids formulated to deter abuse,” FDA Commissioner Scott...