The FDA received no comments on the draft guidance titled Facility Readiness: Goal Date Decisions Under GDUFA, and, as such, has finalized the guidance with only minor editorial changes.

The advance prepublication of the Federal Register Notice (here) notes, “[U]nder the commitment letter related to the GDUFA authorization for fiscal years 2018 through 2022 (under the Generic Drug User Fee Amendments of 2017), a goal date was assigned without regard to facility readiness for inspection. In contrast, under the GDUFA III commitment letter, FDA agreed to assign a longer goal date if a facility is not ready for an inspection at the time of application submission. An application containing a facility not ready for inspection is more likely to require more than one assessment cycle, extending the time required for possible approval and potentially delaying patient access to quality generic drugs. This change in goal date assignment will help FDA to focus resources on applications with facilities ready for inspection.”

While the final guidance has not yet been published on the What’s New page of the FDA website, it can be found here. The guidance is proposed to ensure that, at the time of original ANDA submission, ANDAs are substantially complete. Therefore, the guidance does not apply to:

  • Facilities involved in bioequivalence and clinical studies used to support an application
  • Amendments submitted after a complete response or tentative approval letter
  • Supplements or amendments to a supplement

“The commitment outlined in this guidance sets the goal date to 15 months for an original ANDA containing a certification that a facility on Form FDA 356h is not ready for inspection” (emphasis added). This gives both the firm and the FDA the ability to concentrate on applications that are most likely to be fully evaluated or approved in the original ten-month cycle for applicants with facilities certified as ready for inspection.

Applicants can amend their ANDAs once their facilities are ready for inspection and reset their goal dates; however, firms with sites that are still not ready for inspection thirty days before their fifteen-month original goal date will have their review clocks reset to another fifteen-month period (for a total of thirty months) from the date of their original submission.

The guidance goes on to explain the process for notification of readiness for inspection and the required information on the FDA Form 356h relative to facilities used in the manufacturing, testing, and packaging of a drug product.