Unauthorized Use of Content on this Site: 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 correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.
PAAB Advisory - RWE: Single Arm Studies for Previously Treated Patients
-
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.
