What should an MSL include in a scientific exchange record?

The HCP and their institution, the date and channel, everyone present, the topics discussed and who raised each one, the materials shared with their version, any unsolicited question in the HCP's own words, any safety mention and when it was reported, observations that may become insights, and the follow-up owed.

How soon after a visit should an MSL document the interaction?

As soon as practical after the visit. No public FDA or industry standard sets a number of hours, so the company's own field procedure governs.

Does an MSL need to document an unsolicited off-label request?

Yes. FDA's December 2011 draft guidance recommends keeping records of the nature of the request, including the requester's name, address and affiliation, the information provided, and any follow-up. A 2021 position statement from APPA, IFAPP, MAPS and the MSL Society also says off-label requests need to be documented in an appropriate way.

What happens if a sales representative was present when an off-label question was asked?

The MSL should record that the representative was present and what was said before the question, then route the question through the medical process rather than answering it in the joint meeting. FDA's 2011 draft treats a request prompted by a sales representative as solicited, so compliance decides how to classify it based on the record.

Does a visit note automatically become a medical insight?

No. A visit note records what happened. An insight is written deliberately, with context and a reason it matters to medical strategy, and goes through the company's insights process. The observation in the note is the starting point.

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