PI (Package Insert / Prescribing Information)
The FDA-required labeling document that defines a drug's approved indication, dosing, and risk information, for clinicians.
PI stands for Package Insert, also called Prescribing Information. It's the FDA-required labeling document for a prescription drug, approved alongside the drug itself, that spells out the approved indication, dosing, contraindications, warnings (including a boxed warning, if the drug carries one), and clinical trial data. It's written for clinicians and pharmacists, not patients, which is what separates it from the PIL, the plain-language version aimed at the person taking the drug.
Everything a promotional claim says about a drug has to trace back to what's actually approved in the PI. A claim that goes beyond the indication, dosing, or population described there is off-label, regardless of how the claim is phrased. That's also the basis for SwishX's claims-linked stage: each implied claim in a generation request is checked against the account's approved claim set, which is itself drawn from the current PI, before anything gets generated.