Hey @lora_nolan
Yes, the mentioned guidance applies equally to new products as it would to established products. The pre-NOC submission pilot is not related to this update. It is an administrative guidance reflecting a process change where we moved from requiring final draft TMA and only accepting 2 core pieces prior to NOC, to accepting submissions for review at any stage of the TMA development and with no limit on number of files (at PAABs discretion). Please refer to the pre-NOC guidance for fees that may apply in addition to the standard initial fee should a TMA update be made mid-review of a pre-NOC APS. There is no difference from a Code application perspective in how a pre-NOC review is applied. The duration guidance also applies to pre-NOC submissions. Once a notice of compliance (NOC) is granted for a product, an APS for the product may contain claims noted in the study duration guidance that are related to “out-of-TMA updates” to TMA studies (these would be data from TMA clinical trials that are not mentioned in the TMA), if these claims and their supporting studies are consistent with the TMA, are pre-planned, published and peer reviewed, and do not pertain to NOC/c products or Class B opioid products. Section 1a of the guidance provides further details for this specific scenario.
