FDA finalizes guidance on pre-submission facility correspondence for priority generic submissions
The US Food and Drug Administration (FDA) has finalized guidance detailing the information that sponsors must submit in a pre-submission facility correspondence (PFC) for priority review of abbreviated new drug applications (ANDAs), prior approval supplements (PAS), or amendments to either of these submission types. The guidance also outlines how the agency will review the information contained in the PFC.The guidance reflects changes made to the content, timing, and assessment of the PFC as outlined in the Generic Drug User Fee Amendments (GDUFA) III program.
The PFC supplies the information that the FDA requires to evaluate the facilities engaged in the manufacturing processes and testing of the drug product. This includes facilities covered by corresponding Type II active pharmaceutical ingredient drug master files (API DMFs) referenced in an ANDA, as well as all sites or organizations involved in bioavailability and bioequivalence studies that support the ANDA.
The guidance finalizes a draft version issued on 5 December 2022. (RELATED: FDA revises ANDA facility correspondence draft guidance, Regulatory Focus 2 December 2022)
The final version does not differ significantly from the draft. Minor changes were made in Table 1, which outlines the facility information to be submitted in the PFC for a priority ANDA.
The guidance addresses the contents of a PFC for drug substance and drug product manufacturing facilities, testing facilities, clinical bioequivalence study sites and organizations, and analytical bioequivalence sites and organizations.
The document also covers the FDA’s assessment of the PFC, when the PFC should be submitted to be eligible for priority review, and how the agency will communicate to sponsors as part of their assessment of the PFC.
In order to qualify for a priority review goal, an applicant should submit a PFC no later than 60 days prior to submitting the ANDA.
The guidance states that, “In general, under the terms of the GDUFA III commitment letter, if the PFC is found to be incomplete or inaccurate, or there are significant changes to information contained in a PFC when submitted in the ANDA, or if information received in a final bioequivalence study report included in the ANDA leads FDA to a decision that an inspection is necessary, the 10-month standard review goal will generally apply instead of the priority review goal.”
The PFC must be submitted in the electronic common technical document (eCTD) format.
The guidance includes a series of questions and answers at the end as well as a glossary of terms. Table 1 has a list of facility information that should be submitted in the PFC for priority review.
Final guidance; Announcement
