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.