WASHINGTON, Jan. 21 -- Food and Drug Administration has issued a notice called: Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints To Support Accelerated Approval; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Jan. 21 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval." When finalized, this guidance will provide recommendations to sponsors about using minimal re...