Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry

Issue Date: September 23, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): User Fees, Generic Drugs
Status: Final

Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry

This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how to comply with the self-identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.

Download the Guidance Document