FDA-NIH 2024: CDER's Guidelines for First-in-Human Trials

This presentation outlined CDER's clinical considerations for First-in-Human trials and presented general good practices for FIH study design. The session provided an IND overview, identified common pitfalls encountered during the submission process, and highlighted helpful resources available to sponsors. Key clinical strategies for successful FIH trial planning and execution were discussed to support effective regulatory submissions.

Timestamps

00:28 – General Good Practices for FIH Studies

01:11 – IND Overview

09:07 – Common Pitfalls

09:44 – Helpful Resources

Speaker:

Caitlin Tydings, MD
Pediatric Hematologist/Oncologist
Medical Officer, Division of Oncology 3
OOD | OND | CDER

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fda-nih-regulatory-dos-and-donts-tips-fda-09042024

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