Panel · Use case · Medical Affairs

Good-Practice Statements.

LiveConsensus Delphi

Which statements should govern how we answer unsolicited off-label questions from clinicians?

SetCandidate practice statements for answering unsolicited off-label questions

SeatsMedical, medical information, compliance, regulatory

ReaderMedical information leads

Not askedA standard operating procedure

DepthStandard, four seats

Good-Practice Statements is a ready-made use case for Medical Affairs. It ships under the Consensus Delphi template.

For medical affairs leads. You get each seat's stance on every statement, where consensus holds, the residual disagreement and the consensus statement with its limits. 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

Which statements should govern how we answer unsolicited off-label questions from clinicians?

Who rates

FDA has published draft guidance on responding to unsolicited requests for off-label information. The candidate statements are tested against it and against practice.

Seat	What it rates from	Why it is at the table
Global Medical Affairs Director	Whether each statement protects clinicians’ access to accurate scientific information.	Clinical practice.
Medical Information Services Master	Whether each statement can be applied by an enquiry team.^{1U.S. Food and Drug Administration. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices: draft guidance for industry. December 2011.}	Enquiry practice.
Global Commercial Compliance Officer	Whether each statement keeps the response non-promotional.^{1U.S. Food and Drug Administration. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices: draft guidance for industry. December 2011.,2Code of Federal Regulations. 21 CFR 202.1: Prescription-drug advertisements.}	FDA’s guidance and the regulations.
Regulatory Strategist	Whether each statement is consistent with the labeling.	The label.

What the run does

Unsolicited is the test. The statements distinguish a request the clinician initiates from one the company prompted. The seats rate whether each statement keeps that line.^{1U.S. Food and Drug Administration. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices: draft guidance for industry. December 2011.}

Statements stay practical. Each statement is rated on whether an enquiry team could follow it without further interpretation.

Context for review, not legal advice. The consensus statement is context for the company’s own compliance review.^{2Code of Federal Regulations. 21 CFR 202.1: Prescription-drug advertisements.}

Recommended length

Standard

Four disciplines each rate every statement. Standard depth gives one round with seat counts and the residual disagreement in about four pages.

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

Assumptions the run makes

The run states the assumptions behind its statements and its rule, and says what each gap limits. Examples for this set:

The request in the example is unsolicited.
The guidance cited reflects current agency thinking.
The enquiry team can document each response.

Standards, guidance and sources

Frame

FDA draft guidance on responding to unsolicited requests for off-label information.^{1U.S. Food and Drug Administration. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices: draft guidance for industry. December 2011.}
21 CFR 202.1, Prescription-drug advertisements.^{2Code of Federal Regulations. 21 CFR 202.1: Prescription-drug advertisements.}

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

What gets flagged

Any statement that sounds like promotion, any statement on which compliance and medical seats split, and any statement rated without a reason.

What arrives

The statements and the consensus rule
Verdict and status
Independent first pass, by seat
Agreement by statement
Movement after feedback
Residual disagreement and cruxes
What a real Delphi would add
The consensus statement and its limits

What it will not do

The agreement is a simulation by AI specialists and not a Delphi with real experts. The consensus rule is fixed before any result, and agreement is not correctness.

This is not legal advice and does not replace the company’s compliance review.

It is a simulation by AI specialists and not a Delphi with real experts. A small panel of three to five seats is below every panel size found in the literature, and the report says so.

It does not treat agreement as truth. Consensus is not correctness.

It does not change the rule after seeing the result.

References

[1] U.S. Food and Drug Administration. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices: draft guidance for industry. December 2011. Title and date as known from FDA’s listing; its current status was not checked.
[2] Code of Federal Regulations. 21 CFR 202.1: Prescription-drug advertisements. Known from the eCFR; the text was not read in this pass.

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.

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