USFDA Issues Final Guidance for PFC For Prioritized ANDAs

USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug submissions. This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC).

Under section 505(j)(11) of the FD&C Act, an 8-month Priority review of original ANDAs is provided for as compared to the standard 10-month goal date and this is also identified in the GDUFA III commitment letter for ANDAs, PASs, PAS amendments, and ANDA amendments that are designated priority by FDA. A PFC helps FDA determine the need for a Pre-Approval Inspection (PAI) earlier in the ANDA assessment process. The USFDA’s Manual of Policies and Procedures (MAPP) 5240.3, ‘Prioritization of the Review of Original ANDAs, Amendments, and Supplements,’ defines public health priorities, or “prioritization factors,” that can make an ANDA eligible for a priority review. This includes Drug Shortages or Public Health Emergencies, Limited Competition (Not More Than Three Approved Drug Products), Applications Containing a Paragraph IV Certification, Submissions for Which Final Approval is Dependent on Expiration of Patent or NDA Exclusivity, Sole Source Drug Products.

A drug applicant should submit a PFC no later than 60 days prior to the date of ANDA submission and should provide the information necessary for FDA to determine the need for a preapproval inspection. The PFC should include information on all facilities involved in the manufacturing and testing of the drug product, including the active pharmaceutical ingredient API and all sites involved in bioavailability/bioequivalence (BA/BE) analytical and clinical studies. The information provided should include a description of the manufacturing process, controls of critical steps, and anticipated differences between pilot/exhibit scale and commercial scale processes. Information regarding the conformance of exhibit batches to specifications should be provided.

The information contained in a PFC related to manufacturing process development, description of the manufacturing process, controls for critical steps, sterilization validation, specifications, and batch analyses allows FDA to assess whether manufacturing operations were designed and implemented based on development data and determine the need for a PAI. The cover letter accompanying the PFC should include Statement of inspection readiness of the facilit(ies).

The final bioequivalence study report is not mandatory to be submitted along with PFC and the facility information to be submitted is limited to that which is required for FDA to determine a PAI is required or not. If an applicant submits the BE study report along with PFC and FDA determines that an inspection is needed, the priority goal date may still apply. However, if final BE study report is submitted along with ANDA and FDA determines an inspection of the relevant site or sites is necessary, the standard 10-month goal date will apply.

The PFC is submitted electronically and there are no user fees associated with the PFC; an ANDA filing fee is paid at the time of the original ANDA submission. FDA acknowledges the receipt of the PFC, however eligibility for the priority review goal based on the PFC is determined by FDA only when an ANDA is submitted.

References:

• USFDA Guidance: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (June 2025)
• USFDA: MAPP 5240.3 Rev. 6: Prioritization of the Review of Original ANDAs, Amendments, and Supplements