Panel · Use case · Pharmacovigilance

Medical Information Response Review.

LiveDocument Review

Is this reply to an unsolicited off-label safety question accurate, balanced and correctly routed for adverse event reporting?

DocumentA medical information reply to an unsolicited off-label question

LanesMedical information, safety, medical, compliance

ReaderMedical information leads

Not askedA new reply

DepthStandard, four seats

Medical Information Response Review is a ready-made use case for Pharmacovigilance. It ships under the Document Review template.

For drug safety leads. You get an item-by-item ledger with verdicts and risk, the substantiation each claim needs, the required changes and what the review could not check. 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

Is this reply to an unsolicited off-label safety question accurate, balanced and correctly routed for adverse event reporting?

Who reviews

FDA has issued draft guidance on how a company may respond to an unsolicited request for off-label information. Adverse events mentioned in an enquiry must be routed for reporting.

Seat	What it reviews	What it works from
Medical Information Services Master	Whether the reply answers the question asked and is scientifically balanced.^{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 Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices: draft guidance for industry.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.}	Standard response documents and the literature.
Head of Pharmacovigilance	Whether any adverse event in the enquiry was captured and reported on time.^{2Code of Federal Regulations. 21 CFR 314.80: Postmarketing reporting of adverse drug experiences.}	Reporting regulations.
Global Medical Affairs Director	Whether the data cited are accurate and presented in context.	The cited publications.
Global Commercial Compliance Officer	Whether the reply stays a response and does not become promotion.^{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 Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices: draft guidance for industry.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.}	FDA’s guidance on unsolicited requests.

What the review does

Unsolicited and non-promotional. The reply must answer the specific question and be balanced and not promotional. The ledger marks sentences that go beyond what was asked.^{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.}

An adverse event is a reporting trigger. If the enquiry describes an adverse event, it enters the safety process whatever the reply says. The safety seat checks that the routing is documented.^{2Code of Federal Regulations. 21 CFR 314.80: Postmarketing reporting of adverse drug experiences.}

Balance. The review checks that limitations and contrary data are included where relevant, and not left out.

Recommended length

Standard

Four lanes bear on this document. Standard depth gives each a seat, the ledger and the substantiation table in about four pages.

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

Assumptions the review makes

The review states what it assumes about the document and the material supplied, and says what each gap limits. Examples for this document:

The request was truly unsolicited.
The reply cites the full relevant literature.
The enquirer is a healthcare professional.

Standards, guidance and sources

Framework

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 314.80, postmarketing reporting of adverse drug experiences.^{2Code of Federal Regulations. 21 CFR 314.80: Postmarketing reporting of adverse drug experiences.}

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

What gets flagged

Any sentence that goes beyond the question, any adverse event with no documented routing, and any data cited without its limitations.

What arrives

The document under review
Overall recommendation
The review, by seat
Item-by-item ledger
Substantiation and evidence gaps
Required changes and conditions for approval
Rebuttal round
What this review could not check

What it will not do

This is analyst judgment from AI specialists and not a regulatory, medical or legal sign-off. It cannot check original data or the approved label, and the decision stays with you.

It does not decide whether a report is required in a given country.

It is analyst judgment from AI specialists and not a regulatory, medical or legal sign-off.

It does not rewrite the document. It states the change and leaves the writing to the author.

It does not check original data or the approved label held by the company. Those checks need a real reviewer.

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 314.80: Postmarketing reporting of adverse drug experiences. 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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