FDA Issues Draft Guidance on Developing Drugs to Treat Malaria

FDA Issues Draft Guidance on Developing Drugs to Treat Malaria The Food and Drug Administration (FDA) issued a draft guidance, "Malaria: Developing Drugs for Treatment" on Sept. 22. This guidance is designed to assist sponsors in developing drug and biological products intended to treat malaria. The document serves as a framework for ongoing discussions among FDA, industry, academia, and other parties regarding the design and conduct of clinical trials for malaria treatments. Malaria is primarily transmitted by the Anopheles species of mosquitoes and is endemic in most tropical countries. Clinical manifestations, including its severity, depend on the infecting Plasmodium species and host factors. This draft guidance considers nonclinical and early phase clinical development as well as efficacy (including primary and secondary endpoints) and safety considerations for clinical trials for potential malaria treatments. It also discusses drug development for the different severities of malaria, such as uncomplicated and complicated/severe disease. https://www.fda.gov/media/188817/download?utm_medium=email&utm_source=govdelivery