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Guidance on Code Application

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PAAB Notice
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

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  • As we develop the draft RWE document, we wanted to create a space to share your questions and for you to ask additional questions.

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    5 Topics
    8 Posts
    Jennifer CarrollJ
    Hello @Manufacturer and @Agency PAAB is sending you off into the weekend with some more exciting news. Based on an assessment of the RWE/D submissions since launch of the RWE/D Guidance, PAAB has consulted with the RWE Expert Committee and revised it's approach to allow presentation of some single arm studies of previously treated patients. This revision adds flexibility and does not impact past approvals. If you'd like to learn more, please check out the PAAB Advisory - RWE: Single Arm Studies of Previously Treated Patients. If you have any questions, please post them below. Once again we'd like to thank the expert committee for working diligently to ensure that RWE/D presentations promote informed clinician decision-making while maintaining a long-standing tradition of truthful and trustworthy advertising.