Federal Register Notice: FDA is making available a draft guidance for industry, Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis. This draft guidance addresses issues on developing therapy for prophylaxis and treatment of malaria. Specific topics include recommendations for preclinical development, clinical trial study design, the use of microbiological testing during clinical trials, and statistical considerations. To download this guidance, click here. To view this notice, click here.