CDER SBIA Update: Human Drug Compounding Outsourcing Facility Fees and Draft Guidance for Generic Opioid Drug Development

1. Outsourcing Facility Fee Small Business Application Period

The deadline for requesting a small business reduction for the FY 2017 outsourcing facility annual establishment fee is April 30, 2016. To request the small business fee reduction, complete FDA Form 3908 and submit as directed on the form. To request a reduction of FY 2017 fees, FDA must receive requests by April 30, 2016. Requests received after this deadline will not be considered. To determine whether you would qualify for the fee reduction, refer to the information provided on the Human Drug Compounding Outsourcing Facility Fees webpage.

2. General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products; Draft Guidance for Industry

This guidance is intended to assist a potential applicant 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 has the potential for abuse and which references an opioid drug product with abuse-deterrent properties described in its labeling. It recommends studies, including comparative in vitro studies, that should be conducted by the potential ANDA applicant and submitted to FDA in an ANDA 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.

Federal Register Notice

Guidance Document

FDA News Release