
(AGENPARL) – SILVER SPRING gio 08 giugno 2023 This is a letter issued to a requester that briefly describes CDER’s thoughts on the potential value of a biomarker and encourages further evaluation. This LOS does not imply qualification of a biomarker and does not endorse a specific biomarker test or device. It is meant to enhance the visibility
Fonte/Source: http://www.fda.gov/drugs/biomarker-qualification-program/letter-support-los-initiative