USFDA Guidance: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

The U.S. Food and Drug Administration (FDA) has released an updated guidance "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions" aimed at enhancing the efficiency and predictability of the abbreviated new drug application (ANDA) review process—specifically for prioritized generic submissions. This June 2025 document outlines the optimal use of Pre-Submission Facility Correspondence (PFC) to support GDUFA III performance goals, minimize review delays, and expedite access to affordable generics.

What Is Pre-Submission Facility Correspondence (PFC)?

A PFC is an early submission of facility-related information made before the ANDA itself. It allows the FDA to pre-assess whether inspections will be required, supporting the assignment of a shorter 8-month priority review goal (vs. the standard 10 months).

Eligibility: Applies to:

• Priority original ANDAs

• Prior approval supplements (PASs)

• PAS/ANDA amendments

The PFC mechanism enables:

• Faster inspection planning

• Streamlined data validation

• Earlier identification of quality concerns

• Priority review assignment for qualifying ANDAs

Key Features of the Updated Guidance

1. Enhanced Timelines and Priority Review

• Priority Review Eligibility: To qualify for priority review, applicants must submit a complete PFC at least 60 days before the ANDA submission.

• Assessment Cycle Efficiency: Early facility information allows the FDA to determine inspection needs sooner, reducing the risk of delays and potentially minimizing the number of review cycles.

2. Required Content of the PFC

The PFC must include:

• Comprehensive Facility Details: Names and addresses of all facilities involved in drug substance and drug product manufacturing, testing, and packaging.

• Bioequivalence Study Sites: Information on all clinical and analytical sites conducting bioequivalence studies supporting the ANDA.

• Type II Drug Master Files (DMFs): If applicable, details of referenced API DMFs.

• Manufacturing Process Descriptions: Sufficient detail to enable FDA’s risk-based inspection decisions.

3. Submission Format and Process

• Electronic Submission: PFCs must be submitted in the electronic common technical document (eCTD) format via the FDA’s Electronic Submissions Gateway (ESG).

• Pre-Assigned ANDA Number: Applicants must obtain a pre-assigned ANDA number before submitting the PFC.

4. FDA Assessment and Communication

• Acknowledgement Letter: The FDA will confirm receipt of the PFC and notify the applicant if the submission is complete.

• Goal Date Assignment: If the PFC is deemed complete and no significant changes occur, the ANDA will be eligible for a shortened priority review timeline.

• Inspection Decisions: The FDA uses the PFC to determine if pre-approval inspections are necessary, applying a risk-based approach focused on critical quality attributes.

5. Consequences of Incomplete or Inaccurate PFCs

• Standard Review Timeline: If the PFC is incomplete, inaccurate, or if significant changes are made in the ANDA, the application may revert to the standard 10-month review goal instead of the priority timeline.

• Inspection Triggers: New information in the ANDA (e.g., final bioequivalence study reports) may prompt additional inspections, affecting review timelines.

For more details, refer to the official guidance here: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.