Solutions Circle: How Soon Can I Implement This? "Navigating FDA Submissions and Review Logistics: A One-Stop Guide

Description: Be it during development under an active IND or post-approval of an NDA/BLA, when changes need to be implemented, the regulatory professionals on the team are tasked with determining information needed to assess the substantiality of the change as well as provide a timeline needed to interact with the regulatory authorities to give a “go-ahead” to the internal team. The respective commercial and clinical teams are relying completely on this to ascertain that they can conduct their business in a compliant manner and often want to know the fastest way to get a regulatory “nod”.

There are guidances and references providing information on the regulatory strategies that need to be considered while assessing the significance of the change. However, very often the RA team is making determinations on the timing of submission, review, and approval from the FDA. An understanding of the FDA Division’s expectations as well as rapport with the FDA PM with clear and open communication goes a long way to assisting the RA team in providing firm timelines.

This session will serve as a one-stop guide for the RA professionals to plan and determine the submission logistics associated with both IND amendments as well as post-approval NDA supplements. Alongside references to critical FDA MAPPs and guidances, this interactive session will aim to provide easily accessible tables/cheat sheets to quickly assess timelines based on the significance of change and submission types. A couple of case studies will be presented to assist in decision-making on complex scenarios.