A biomarker, clinical outcome assesment, or any other method, material, or measure determined to aid drug development and regulatory review (FD&C Act, section 507(e)(5)).

This is just here as a test because I lose it

Term information

definition source

https://www.fda.gov/media/133511/download

see also

https://pubmed.ncbi.nlm.nih.gov/29110507/

Term relations

Subclass of: