Infographic | September 9, 2022

Why And When To Hold A Pre-IND Meeting With FDA


Why do I need a pre-IND meeting?

This is a common question from drug developers and has a straightforward answer:

The key reasons to have a pre-IND meeting are to limit the risk of regulatory surprises, establish a relationship early with the FDA review Division, and give them a heads up that your IND is coming. It is worth adding that there is no cost (fees payable to FDA) associated with pre-IND meetings, and that the sponsor has the option to request written responses in lieu of a meeting – to simplify the process when warranted.

access the Infographic!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Cell & Gene? Subscribe today.

Subscribe to Cell & Gene X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Cell & Gene