Guidance Breakdown: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
A new final guidance explains how to lock in the 8-month priority review goal for eligible ANDAs through a complete, timely Pre-Submission Facility Correspondence (PFC).
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The FDA just finalized its guidance “ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions.”
The document ties directly to the Generic Drug User Fee Amendments III (GDUFA III, FY 2023-2027) performance goals and explains how applicants can secure the shorter 8-month priority review goal for eligible original ANDAs, PASs, PAS amendments, and ANDA amendments.
The catch? Applicants must file a complete and accurate PFC—a stand-alone eCTD sequence—no later than 60 days before the application and no earlier than 90 days to avoid mid-stream changes. Miss the mark, and the FDA defaults to the standard 10-month goal.
Let’s break this guidance down into the need-to-knows.
Eligibility and scope
Only submissions that already qualify for priority—under FD&C §505(j)(11) or CDER's Prioritization MAPP—may leverage a PFC.
That scope covers original ANDAs, PASs, PAS amendments, and ANDA amendments. Again, fail to meet the PFC rules and the application can still be filed, but the FDA will slide it onto the standard 10-month track.
The 60/90-day timing rule
The FDA will accept exactly one PFC per application. To keep your place in line:
Submit between Day -90 and Day -60. Earlier filings invite "significant changes"; later ones miss the window.
Declare—at ANDA filing—that nothing in the dossier has changed since the PFC, or identify and justify any exceptions.
Real-world calendar examples in the guidance do a good job of illustrating how weekends and federal holidays shift the 60-day cutoff—definitely review this in detail.
Administrative setup requirements
Two things to be aware of here:
Pre-assigned ANDA numbers: For original ANDAs, applicants must request a pre-assigned ANDA number before submitting the PFC. PASs, PAS amendments, and ANDA amendments should use the existing ANDA application number.
Withdrawal procedures: If you decide not to submit the ANDA after filing a PFC, notify FDA in writing via eCTD section 1.2 with the cover letter titled "WITHDRAWAL REQUEST – PRE-SUBMISSION FACILITY CORRESPONDENCE" in bold, uppercase letters
What goes into a “complete and accurate” PFC
FDA built Table 1 so reviewers can decide before the ANDA arrives whether a pre-approval inspection (PAI) is needed.
A few highlights to pull out here:
Drug-substance & drug-product sites: Must-haves include site name, FEI & DUNS, operations performed, process description, development/validation data, batch analyses, sterilization validation, and exhibit vs. commercial scale differences. The FDA wants this information as it allows them to make a risk-based call on a PAI.
Clinical BE sites: Must-haves here include site roster, investigator list per ICH E3 §16.1.4, study IDs, conduct dates, and protocols/amendments. This information drives the decision about a BIMO inspection.
Analytical BE sites: Must-haves include lab name/address, study numbers, validation status, method IDs, and draft or final study report (if available). This confirms data integrity for PK/PD and in vitro studies.
Combination products: For combination products, information regarding non-drug constituent parts and their manufacturing/testing facilities must also be incorporated into the eCTD sequence.
Packaging and transmission
The guidance instructs firms to file the PFC as its own eCTD sequence via the Electronic Submissions Gateway. (Choose “CDER” and “eCTD” for center and type.)
Also, the cover letter title must shout “PRE-SUBMISSION FACILITY CORRESPONDENCE” in bold, uppercase letters. Attach a Form 356h since the FDA uses it to route and clock the submission.
Certifying inspection readiness
The PFC must confirm every manufacturing facility—including Type II DMF holders—is inspection-ready at submission. CROs and analytical labs do not need to certify readiness until the FDA reviews the ANDA.
Special provision for original ANDAs: If a plant falls out of readiness at ANDA filing, the FDA will push the goal date to 15 months unless you restore readiness ≥30 days before that longer goal expires. If readiness is restored in time, the FDA will reassign a priority goal date from the date of the amendment submission.
Guardrails against “significant changes”
Any shift in listed facilities, manufacturing operations or principles, or the order of unit operations between PFC and ANDA is a significant change. This is crucial to understand, as it instantly resets the clock to the 10-month standard goal. Minor tweaks—like finalizing process parameters without redesign—generally aren’t significant, but the burden is on you to justify.
Final BE study report considerations
While final BE study reports aren't required in the PFC under GDUFA III terms, there's an important nuance:
If submitted with PFC: Priority goal may still apply even if FDA determines inspection is needed.
If submitted only with ANDA: If FDA determines inspection is needed based on the final report, the standard 10-month goal applies.
What the FDA sends back
Two things:
PFC Acknowledgement Letter — This is a simple receipt with no goal date.
ANDA Acknowledgement Letter — After the ANDA lands, the FDA confirms priority status and assigns the 8- or 10-month goal.
There is no user fee for the PFC. The normal ANDA fee still applies at the time of application filing.
A few action items we recommend
Here are a few initial steps we recommend teams consider to operationalize this guidance.
Build a PFC master tracker. Capture FEI, DUNS, operations, inspection history, and readiness date for every manufacturing, packaging, testing, BE, and analytical site. Keep it alive in change control.
Establish pre-assigned ANDA number procedures. For original ANDAs, build this request into your submission timeline well before the PFC preparation phase.