WASHINGTON, Sept. 23 -- Food and Drug Administration has issued a notice called: Malaria: Developing Drugs for Treatment; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Sept. 23 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Malaria: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the overall development program for drug and biological products for the treatment of malaria, caused by clinically relevant Plasmodiumspecies.
For more information, contact Elizabeth O'Shaughnes...