The When, What, How, and Why of FDA Engagement with Niki Gallo

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Today, Niki Gallo, principal consultant of regulatory affairs at Halloran Consulting, joins host Emily Walsh Martin for a deep dive into timeline management pitfalls, the nuances of INDs, and the rapidly evolving FDA landscape. Niki brings to the program her extensive experience shepherding innovative therapeutics through the regulatory process and timely insights into the complexities of transitioning from the bench to the bedside.

Whether you’re from industry or academia, today’s conversation will help wrap all our heads around testing novel therapies for the first time in humans.

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Music by: https://www.steven-obrien.net/
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Bright New Morning - Steven O'Brien

(Used for free under a Creative Commons Attribution 4.0 License: https://creativecommons.org/licenses/by/4.0/)

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