WASHINGTON, Sept. 25 -- Food and Drug Administration has issued a notice called: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Sept. 25 by Grace R. Graham, 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of a draft document entitled "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry." The draft guidance document provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditi...