On June 19, 2017, the US Food and Drug Administration (FDA) released the draft guidance on the priority review of the applications for generics entitled” ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.”

The Pre-Submission Facility Correspondence (PFC) process has been identified by the FDA as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization for Fiscal Years 2018-2022 (GDUFA II).

According to the FDA, receiving a complete and accurate PFC from the sponsor, two T three months ahead of their abbreviated new drug application, will allow the Agency to begin the facility assessment process in advance of the planned abbreviated new drug application (ANDA) submission and therefore shorten its review process by two months. During the two months lead time, the agency will have the opportunity to determine whether facility inspections will be needed, and if it does, it can initiate the inspection planning earlier in the review process of the ANDA.

In the draft guidance, FDA details the information and format that sponsors must include in their PFCs, which includes:

  • General information, including the planned ANDA pre-assignment number.
  • PFC submission date, and the applicant’s identifying information.
  • Statement of ANDA eligibility for priority review.
  • Manufacturing process and testing facility information.
  • Bioequivalence summary and site/organization information.

However, FDA cautions sponsors to ensure they get everything right in the PFC the first time around, otherwise they will risk receiving a standard review timeframe, as FDA does not expect to utilize its limited resources to review a second PFC on the same submission if the first one is deficient.

For more information check the link to the draft guidance https://www.gpo.gov/fdsys/pkg/FR-2015-0918/pdf/2015-23389.pdf.

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