224 - I have been contracted by an agency to help develop a program for doctors on a product for an arthritic condition with a high indication of depression and anxiety in patients. No claims are made in the program regarding the drug. The program simply offers education and tools on depression and anxiety in these patients with this arthritic condition. What are the PAAB guidelines that must be adhered to in this program? Thanks!
Jennifer Carroll last edited by
This sounds as though it is a product branded app. All PAAB code provisions would apply. For example, all content offered through the app (whether treatment or disease related) would need to be on-label for that product. It's hard to provide more specific information without seeing the specific APP. If you'd like to receive guidance before getting too far into the project, I suggest submitting what you are envisioning for a written PAAB opinion. This is a great way to learn about key red flags while you are still early in the process. The fee schedule for an opinion is on our website. Call the PAAB office and ask to speak with one of our file coordinators if you'd like information on how to submit a request for an opinion.