Thursday, June 25, 2026
🇺🇸 FDA

Regulatory Tools — FDA Review Planning

PDUFA Date Calculator

Estimate a likely FDA action-date target for NDA, BLA, and resubmission reviews from a receipt or filing date. Built for regulatory affairs teams, BD/licensing, and biotech investors — not legal or regulatory advice.

Quick Answer

This PDUFA date calculator estimates the FDA target action date for NDA, BLA, and resubmission reviews from a receipt or filing date and review designation. Standard original applications target 10 months from filing (about 12 months from receipt); priority review targets 6 months from filing. Class 1 and Class 2 resubmissions use 2- and 6-month clocks from receipt. Confirm any estimate against sponsor SEC 8-K filings and FDA correspondence.

Common PDUFA Planning Rules

Standard original NDA/BLA

10 months from filing, about 12 months from receipt

Priority original NDA/BLA

6 months from filing, about 8 months from receipt

Resubmissions

Class 1: 2 months | Class 2: 6 months from receipt

FDA Action-Date Estimator

Enter the date from FDA correspondence and select the review pathway.

Application & filing dates
Review designation

Estimated FDA action-date target

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Entered date -
Estimated filing date -
Review clock used -

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How to Use the PDUFA Date Calculator

  1. Select NDA, BLA, or resubmission to match the application type in FDA correspondence.
  2. Enter the FDA receipt date or filing date. For resubmissions after a CRL, use the resubmission receipt date.
  3. Choose Standard Review, Priority Review, or Class 1/Class 2 resubmission based on the acceptance or resubmission letter.
  4. Review the estimated action-date target, filing-date assumption, and review clock — then confirm against SEC 8-K disclosures and regulatory counsel.

Worked Example

Scenario: Original BLA accepted for priority review; FDA receipt date January 15, 2026.

Filing date estimate: receipt + 60 days ≈ March 16, 2026 (60-day filing review).

Priority clock: 6 months from filing ≈ September 16, 2026 PDUFA target.

Next step: When the sponsor discloses the official date in an 8-K, compare it to this estimate and update BD or rNPV models accordingly.

Pharma & BD / licensing context

PDUFA timing drives milestone payments, rNPV sensitivity, and competitive launch assumptions in licensing and M&A diligence. When a target asset lacks a disclosed goal date, this calculator provides a conservative planning anchor from acceptance correspondence. Pair estimates with our rNPV Calculator to stress-test probability-weighted value around approval catalysts.

Post-approval economics depend on exclusivity windows and submission sequencing. After estimating a PDUFA date, model Orange Book or biologic exclusivity with our Exclusivity Period Calculator and map pre-approval CMC and clinical milestones in the Submission Timeline Builder.

For publicly disclosed catalysts already announced by sponsors, cross-check estimates against our PDUFA Calendar 2026 and verify every date via SEC Form 8-K before investment or regulatory decisions.

When to Use Conservative Caveats

Major amendments Substantial new CMC or clinical data during review can extend the PDUFA goal date by up to 3 months under PDUFA VII rules.
Inspections and labeling Manufacturing inspection readiness, labeling negotiations, REMS, and facility status can affect whether FDA acts on the goal date.
AdCom scheduling Advisory Committee meetings may occur near the goal date; FDA is not bound by panel votes but post-meeting work can shift timing.
FDA correspondence controls Always reconcile this estimate with the filing communication, review designation letter, SEC 8-K disclosures, and any later FDA updates.

Evidence & sources

Frequently Asked Questions

A PDUFA date is the FDA target action date for completing review of a human drug or biologic marketing application under Prescription Drug User Fee Act (PDUFA) review goals. It is a performance target tied to user-fee commitments, not a guarantee of approval on that calendar day.
For original NME NDAs and original BLAs filed under the PDUFA program, the substantive review goal is 10 months from the 60-day filing date — approximately 12 months from FDA receipt when the filing review period is included. Non-NME original NDAs use 10 months from receipt. This calculator lets you choose whether the entered date is receipt or filing.
Priority review is generally targeted at 6 months from the filing date for NME NDAs and original BLAs, or 6 months from receipt for non-NME original NDAs. When counting from receipt for NME/BLA filings, add the 60-day filing review period first — about 8 months total from receipt to the goal date.
After a Complete Response Letter, Class 1 resubmissions are generally reviewed within 2 months and Class 2 resubmissions within 6 months from receipt of the resubmission. Exact classification depends on FDA review issues and the sponsor response package. Resubmissions do not use the original 10- or 6-month original-application clocks.
Yes. Major amendments can extend the goal date by up to 3 months. Inspection timing, advisory committee scheduling, labeling negotiations, facility issues, REMS work, and unresolved CMC deficiencies can also delay action. FDA may approve or issue a CRL before the goal date as well. Use calculator output as a planning estimate only.
The PDUFA goal date (also called target action date or user-fee goal date) is when FDA commits to act on 90% of similar submissions under PDUFA performance goals. The actual FDA action date is when FDA approves, issues a Complete Response Letter, or otherwise communicates a decision — which may occur before, on, or after the goal date.
Start with the sponsor’s most recent SEC Form 8-K or earnings release, which usually states the PDUFA target action date verbatim. Cross-check FDA acceptance letters, user-fee goal letters, and subsequent amendments that may have extended the date. Search EDGAR for the company ticker plus “PDUFA” or “target action date” before trading or launch planning.
Biotech investors use PDUFA timelines to map binary catalysts, position sizing, event-driven trades, and portfolio risk around NDA/BLA decisions. Regulatory affairs and BD teams use estimates for rNPV timing, licensing deal milestones, and competitive launch-window modeling when a sponsor has not yet disclosed an official goal date.
Yes for original applications under PDUFA VII: both CDER-reviewed NDAs and CBER-reviewed BLAs generally follow the same 10-month standard and 6-month priority goals (measured from filing for NME/BLA originals). Supplemental applications and manufacturing changes may follow different clocks. Select NDA or BLA in this calculator for labeling clarity; the review math is the same for original filings.
FDA may schedule an Advisory Committee (AdCom) meeting during review, often 1–2 months before the PDUFA goal date for novel or contested benefit-risk profiles. AdCom votes are advisory, not binding, but scheduling and post-meeting labeling work can influence whether FDA acts on or before the goal date. AdCom timing is not modeled in this calculator.
FDA does not publish a forward-looking calendar of all pending action dates. For disclosed targets, use our PDUFA Calendar 2026 hub to filter upcoming NDA, BLA, and supplemental reviews by month, then verify each entry against the sponsor’s latest SEC 8-K before relying on it for investment or regulatory decisions.
Yes, for planning purposes. Enter the FDA receipt or filing date from acceptance correspondence and select standard, priority, or resubmission class. Pair the estimate with our PDUFA Calendar 2026 for disclosed catalysts and re-verify once the sponsor files an 8-K stating the official target action date.

Related Regulatory Tools

PDUFA Calendar 2026 rNPV Calculator Exclusivity Period Calculator Submission Timeline Builder FDA Submission Types Guide

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