Anyone using recent OPDP Warning Letters to coach field teams? I’m a pharmaceutical patent attorney and pair them with a one-page checklist keyed to 21 CFR 202.1 and core IP hygiene (on-label only, no unpublished data, protect trade secrets) during 15-minute ride-alongs. Looking for similarly concise tools you trust to reduce off-label risk and avoid accidental disclosures that could jeopardize patents or trademarks.
I’ve had good results starting each 15-minute ride-along with a 90-second “fix the claim” drill: the rep reads a fresh OPDP excerpt, then rewrites it on-label and points to the PI/ISI they’d show first, using this feed: https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notices-violation-letters. It’s quick and sticks, but I cap it to one claim so it doesn’t turn into a legal seminar — would that fit alongside your 21 CFR 202.1 checklist?