ARO Q&A #8: Time-sensitive Announcements
Q: Can you provide more details around what is considered a time-sensitive announcement?
A: A time-sensitive announcement is a short APS focused on an announcement that requires dissemination in an urgent manner. For example, these announcements may communicate formulary coverage changes, a guideline update, product shortages, availability announcements, etc. We consider an announcement to be 2 pages of new content or less.
• A banner ad with the message “Brand X is now on formulary!”
• A short email detailing issues related to a product shortage
• A post card intended to bring awareness to a new indication, with the message “Now indicated for the treatment of…”
What is not a time-sensitive announcement?
• An APS with a rush timeline that does not focus on any of the above announcements
• A large APS containing diverse content containing an announcement (e.g. a website with efficacy, safety and MOA information that also contains the flash “Now on formulary”)
• A pre-NOC submission
If you are unsure as to whether your piece qualifies as a time-sensitive announcement, please reach out to our team.
Was wondering if we would be able to submit a new indication announcement as a Pre-NOC & ARO submission?
Thanks for your question! We do not currently accept pre-NOC submissions for ARO, regardless of the nature of the announcement. In balancing submissions for all APS types, we must prioritize the review of products with NOC, which can be disseminated immediately, over those which do not yet have NOC and may not be able to be used immediately. The announcement of a new indication may be permitted in the context of a time sensitive announcement, as described above in this thread, however this would only be considered after NOC is received. Please also see this thread, as it relates to rationale on this topic.
@danthony Thank you for the clarification!