Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
PAAB Advisory - RWE: Single Arm Studies for Previously Treated Patients
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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.
