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FDA Issues Industry Guidance for Generic Drug Facilities, Sites & Organizations

November 7, 2016

The US Food and Drug Administration (FDA) has issued Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites and Organizations.

This guidance aims to assist human generic drug facilities, sites, and organizations on how to comply with the self-identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III).

Specifically, this guidance outlines the following:

  • Which types of generic facilities, sites, and organizations are required to self-identify;
  • What information is requested;
  • What technical standards are to be used for electronically submitting the requested information; and
  • The penalty for failing to self-identify.

This guidance was released in September 2016.