WASHINGTON, July 2 -- Food and Drug Administration has issued a notice called: Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on July 2 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Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drug and biological products for the treatment of the myelodysplastic syndromes (MDS). Spec...