Docket Submissions

Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting
FDA 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 Analgesics
FDA 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Draft Guidance for Industry on Assessment of Abuse Potential of Drugs
FDA Docket No. FDA-2010-D-0026

Evaluation of Risk Evaluation and Mitigation Strategy (REMS) Programs
FDA Docket No. FDA-2009-N-0143