Guidance on which HCP materials require review

[tk2022]

I understand there is a decision tree tool uploaded by PAAB titled "Guidance on which HCP materials require PAAB review."

However the response to PAAB Q&A 763 appears to conflict with the tool.

The tool allows for materials that discuss drug therapy or content relating to drug therapy to be PAAB exempt (if you follow the path to the end).
However, the response in Q&A 763 states that disease info materials that mention treatment by name class or category are not PAAB exempt.

Can you please clarify? The Decision Tree makes it seem that these materials are PAAB exempt but the Q&A question states otherwise.

My understanding is the Decision Tree is for any HCP materials which would include unbranded materials. It would be great to see the decision tree updated.

[Jennifer Carroll]

Hey @tk2022

Q&A #763 refers to just one scenario which could render a piece exempt. The tool outlines other factors/scenarios that may or may not render a piece exempt from PAAB pre-clearance.

Can you please provide us with the flow you followed through the tool and the nature of the piece you’re thinking of (unbranded/branded, treatment/no treatment, company generated/independently generated, distribution, etc.)? This will help us better assess the question. (Note 6.6. in the document will be updated to 1.5D per the current code.)