Thursday, June 9, 2022

FDA: Taking Comments on ctDNA Diagnostics in Cancer

I don't think I've flagged this - 

On May 2, 2022, FDA released a draft guidance on use of ctDNA in early tumors.  Comment is open til the end of the month.

Home page at FDA here:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-circulating-tumor-deoxyribonucleic-acid-early-stage-solid-tumor-drug-development-draft-guidance

Comment page at regulations.gov

https://www.regulations.gov/document/FDA-2022-D-0084-0001


Note that  FDA previously produced draft and final documents on minimal residual disease in hematopoietic cancers:  here.