507 - The PAAB does not allow the use of post-hoc study analyses to support claims. Are there any exceptions to this? For example if the post-hoc analysis was done for safety reasons at the request of the FDA, would that publication be permitted to support claims?
Jennifer Carroll last edited by
Post hoc analysis is not accepted as evidentiary support for claims of benefit (PAAB s 3.1.1). The only exception which readily comes to mind is if the data is in the Health Canada approved Terms of Market Authorization.