Zdrowie i gospodarka · 22/11/2017

General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products." This guidance is intended to assist a person who plans to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic version of a solid oral opioid drug product that references an opioid drug product with abuse- deterrent properties described in its labeling. The guidance recommends studies, including comparative in vitro and pharmacokinetic (PK) studies, that a potential ANDA applicant should conduct and submit to FDA to demonstrate that a generic solid oral opioid drug product is no less abuse deterrent than its reference listed drug (RLD) with respect to all potential routes of abuse.