FDA issues Q&A Guidance on GDUFA Self-Identification and Other Important Issues

Today, OGD released an updated version of a Q&A document 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 document provides FDA responses to many questions that have been raised by industry during the administration of GDUFA I.

The Q&A focuses on three specific subjects:

  • Self-Identification of Facilities, Sites, and Organizations
  • Review of Generic Drug Submissions
  • Inspections and Compliance

The “Self-Identification” section contains information on who is required to self-identify, when they must do so, and when the establishment fees are due.  It also defines the responsibilities of repackagers and when they need to self-identify, and discusses API manufacturers’ responsibilities.  There are responses relative to contract sterilizers, if different locations of the same firm need to pay fees and self-identify, as well as a discussion of the penalties for not paying fees and self-identifying.

In the “Review of Generic Drug Submissions” section, there are numerous responses to questions relative to refuse-to-receive, the review of applications, and goal date clock if fees are not paid, or other provisions of GDUFA are not complied with.  Issues regarding extension of goal dates due to different types of amendments are outlined.  Also, responses to questions about paper submissions are addressed.  Honestly, there is nothing new in this section, but there are some good clarifying responses.

The “Inspections and Compliance” section addresses when inspection can be stopped if a fatal flaw is discovered in an ANDA.  It also addresses risk-adjusted parity in the content of foreign inspections, and their timing, as well as defines that term.

A full copy of the Guidance document can be found here.