Generics Draft Abuse-Deterrent Guidance Issues
The questions about what and how a generic abuse-deterrent product has become somewhat more clear with the issuance today of the Draft Guidance for Industry – General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The Guidance document describes the types of tests (comparative in vitro studies and, in some cases, relevant pharmacokinetic or other studies that may be appropriate) that a generic applicant should undertake when seeking approval for a Reference Listed Drug (RLD) opioid product that has abuse-deterrent properties described in its labeling.