Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket SettingFDA Docket No. FDA-2017-N-2903
Evaluation of the Extended Release and Long-Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS)FDA Docket No. FDA-2016-N-0820
Abuse Deterrent Formulations of Prescription Opioid AnalgesicsFDA Docket No. FDA-2010-P-0526, No. FDA-2010-P-0540, No. FDA-2011-P-0473
Draft Guidance for Industry on Assessment of Abuse Potential of DrugsFDA Docket No. FDA-2010-D-0026
Evaluation of Risk Evaluation and Mitigation Strategy (REMS) ProgramsFDA Docket No. FDA-2009-N-0143