Updates to the RWE and Attention Icon Formatting and Expansion for Rare Disease

Jennifer Carroll

To reflect feedback received from healthcare professionals (HCPs) and industry, PAAB is updating the RWE and Attention Icon Formatting Guidance.

The updated formatting standards were co-developed with communication agencies to ensure they meet both regulatory compliance requirements and client needs. This collaborative approach supports implementations that are not only compliant, but also effective in achieving advertising goals.

Additionally, through consultation with stakeholders and experts, PAAB is expanding our approach to advertising for rare diseases, to accommodate presentations from post-hoc studies. Learn more with the updated Attention Icon Guidance.

ATTENTION ICON FORMATTING

The RWE Guidance and Attention Icon Guidance came into effect February 1, 2024 and has allowed for Sponsors to present recent research findings to inform healthcare decision-making in a responsible manner which allows for the limitations of the evidence to be prominently disclosed. These updates are intended to clarify expectations and support consistent application of RWE formatting principles. The updated Guidance is now available on the PAAB website.

The revised approach is aligned with what was presented, discussed, and demonstrated during the PAAB National Workshops.

The updated RWE Formatting Guidance will apply to submissions moving forward. Sponsors are invited to update existing and future materials at their discretion, based on individual business decisions. There is no requirement to revise previously approved pieces (i.e. straight renewals) solely as a result of this formatting update. Any APS undergoing review currently may, but are not required to be updated based on the new formatting; however, all new files will be required to move to the new format effective at the start of Q2, 2026.

Further details and support will continue to be available through existing channels such as General Questions and PAAB Forum.

️ PAAB HOLIDAY HOURS ️
Just a friendly reminder that the PAAB office will close at 12:00pm on Wednesday, December 24th and will reopen at 9:00am on Friday, January 2nd. Please note that the period between closing and reopening is considered non-business time, and emails and phone calls will be returned as soon as possible once we resume operations.

The PAAB staff wishes you a safe and happy holiday season, and we look forward to working with you in the New Year.

PAAB Admin