FDA publishes guidance for industry: GDUFA Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance

Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry

Today, July 26, 2017, the FDA published the guidance for industry entitled “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.”

This guidance is intended to provide answers to common questions the agency receives from the generic drug industry regarding the requirements and commitments of GDUFA related to the self-identification of facilities, sites, and organizations; review of generic drug submissions; and inspections and compliance. The guidance updates and finalizes the related content in the draft guidance titled “Generic Drug User Fee Amendments of 2012: Questions and Answers,” which was originally published in August 2012 and revised in September 2013. In November 2016, FDA updated and finalized the portion of the draft guidance relating to fees in the guidance “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.” If GDUFA II is approved by Congress, new guidance(s) would be issued appropriate.

To comment on the guidance, please visit Docket Number FDA_FRDOC_0001.

Direct link to the guidance:

https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM530476.pdf