This guidance describes the process through which prospective generic drug applicants submit pre-submission facility correspondence (PFC) in advance of priority generic drug submissions.
In 2016-2017, the Food and Drug Administration (FDA), regulated industry, and public stakeholders conducted negotiations concerning reauthorization of the Generic Drug User Fee Amendments (GDUFA II). A chief product of these congressionally mandated discussions is the GDUFA II Commitment Letter. The GDUFA II Commitment Letter describes the FDA’s performance goals under GDUFA II as well as changes and improvements to the user fee program. The performance goals and program enhancements specified in the GDUFA II Commitment Letter concern aspects of the generic drug review program that are important for facilitating timely access to quality, affordable generic medicines.
As one of the enhancements specified in the GDUFA II Commitment Letter, the PFC is a mechanism to achieve expedited review of priority abbreviated new drug applications (ANDAs), prior approval supplements (PASs), and their amendments (collectively ANDAs). Using a PFC, a prospective applicant submits certain information related to manufacturing and bioequivalence facilities (collectively facilities) that will be referenced in a planned ANDA prior to submission of the ANDA itself. Pre-submission facility correspondence should also demonstrate that the planned ANDA meets the criteria for a priority submission. The priority designation criteria are described in the Center for Drug Evaluation and Research’s (CDER) Manual of Policies and Procedures (MAPP) 5240.3, Rev. 2, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (Prioritization MAPP). For example, if the ANDA drug product is the subject of a current drug shortage, the ANDA would potentially qualify for priority
The information submitted in the PFC provides the Agency with the opportunity to determine whether facility inspections will be needed. When deemed necessary, the Agency will initiate inspection planning earlier in the review of the ANDA. Further, it enables FDA to meet the shorter review timeframe (shorter goal dates) for the planned ANDA as defined in the GDUFA II Commitment Letter. If a PFC successfully demonstrates that the planned ANDA may be a priority submission and the information is complete and accurate and is unchanged, the ANDA may qualify for shorter goal dates for the planned ANDA. Absent extraordinary circumstances, FDA does not expect to utilize its limited resources to review a second PFC on the same submission if the first one is deficient.