Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Guidance for Industry

We have adopted this International Scientific Guideline - FDA-2019-D-0359

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas publication date: July 2020

Categories: FDA | Clinical/Medical

TGA annotations: Nil

Where FDA guidelines adopted in Australia include references to US legislation, the requirements contained in the referenced US legislation are not applicable to the evaluation of medicines by the TGA.
The pdf version of this document was downloaded and saved from the U.S. Food and Drug Administration (U.S. FDA) site on 24 April 2024.

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