Panel · Use case · Regulatory

Time to Approval Range.

LiveEstimate Elicitation

How many months from submission to approval should we plan for in the lead market?

QuantityMonths from submission to approval in the lead market

SeatsRegulatory, quality, safety

ReaderRegulatory and launch leads

Not askedA submission plan

DepthStandard, four seats

Time to Approval Range is a ready-made use case for Regulatory. It ships under the Estimate Elicitation template.

For regulatory leads. You get each seat's low, central and high with its anchors, the pooled range and what it is not, and what would narrow it. Claims are cited or marked as gaps.

Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.

The decision

How many months from submission to approval should we plan for in the lead market?

Who estimates

Review clocks are set by the agencies, but actual time depends on information requests, inspections and clock stops. The seats separate the fixed goal from the likely delay.

Seat	What it estimates from	Why it is at the table
VP Global Regulatory Strategy	The formal review clock and the typical gap between goal and outcome.^{1U.S. Food and Drug Administration. PDUFA VII: Fiscal Years 2023–2027.,2European Medicines Agency. Human regulatory overview: marketing authorisation.}	FDA’s user fee performance goals and EMA procedures.
Regulatory Strategist	The chance of a major information request or extension.	Agency practice.
Director Quality Assurance	The chance that inspections or manufacturing findings delay approval.	Inspection history.
Head of Pharmacovigilance	The chance that safety questions extend review.	The safety database.

What the elicitation does

Goal versus outcome. The review goal is a commitment of the agency, not a forecast. The report gives both the goal and the plausible range around it.^{1U.S. Food and Drug Administration. PDUFA VII: Fiscal Years 2023–2027.}

Two systems, two clocks. In the EU the clock stops while the company answers questions, so elapsed time exceeds the active review time. The report states which it estimates.^{2European Medicines Agency. Human regulatory overview: marketing authorisation.}

What would narrow it. The date of the mid-cycle communication or the list of outstanding questions.

Recommended length

Standard

Four angles bear on the number. Standard depth gives each a seat, with the dossier and the reasons for the spread, in about four pages.

You can pick another length on the form. The other two stay available.

Assumptions the elicitation checks

The elicitation states the assumptions each estimate rests on, and says what each gap limits. Examples for this quantity:

The submission is complete at filing.
No inspection of a new facility is required.
The product receives standard and not priority review.

Standards, guidance and sources

Anchors

FDA, PDUFA VII performance goals.^{1U.S. Food and Drug Administration. PDUFA VII: Fiscal Years 2023–2027.}
EMA, marketing authorisation procedures.^{2European Medicines Agency. Human regulatory overview: marketing authorisation.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any month count stated without saying whether it includes clock stops, any assumption of no inspection, and any range narrower than the agency’s own variation.

What arrives

The quantity and how it is judged
Evidence dossier
Seat judgments
Estimates side by side
Why the seats differ
Revised estimates after rebuttal
The pooled range and what it is not
What would narrow the range

What it will not do

The pool is a synthesis of AI judgments and not a calibrated distribution, and the seats are not weighted by performance. It does not narrow the range to look decisive.

It does not promise an approval date.

It is not a calibrated probability distribution. The pool is a synthesis of AI judgments, and the report says so.

It does not weight seats by performance. No calibration record exists for the AI seats.

It does not narrow the range to look decisive.

References

[1] U.S. Food and Drug Administration. PDUFA VII: Fiscal Years 2023–2027. Known from FDA’s site; the performance goals were not read in this pass.
[2] European Medicines Agency. Human regulatory overview: marketing authorisation. Not read in full.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

About the Panel service

Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.

To edit a saved template, open New → Panel → From template, or the library rail on the service form.