The FDA Pre-IND review serves as a crucial checkpoint for sponsors to receive valuable binding feedback on their proposed development plans, providing critical guidance that charts the course for their path to investigational new drug (IND) filing.

The Pre-IND meeting ensures that sponsors are aligned with FDA expectations and recommendations ahead of completing the remaining studies to submit an IND application, including the design of preclinical studies, product manufacturing, and quality controls needed to initiate human studies (CMC), and the design of the planned first-in-human clinical trial.

Utilizing the pre-IND process at the appropriate point in development can lead to more efficient drug development, increasing capital and timeline efficiencies, and potentially accelerating the IND and eventual approval processes by reducing the risk of delays or clinical holds later in development.