Expanded Access Label Requirements in the USA

This topic has 2 replies, 2 voices, and was last updated 9 months, 2 weeks ago by Darrin Sloan.

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November 18, 2023

Expanded Access Label Requirements in the USA

Hi,

Hoping for some direction on the labeling requirements for EAP in the US.

A team is looking to move patients (3) from an ongoing open label clinical trial into EAP in the US.

Thank you!

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