Malaria: Developing Drugs for Treatment

Docket Number:: FDA-2025-D-0918
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Malaria: Developing Drugs for Treatment.” The purpose of this draft guidance is to assist sponsors in the overall development program for drug and biological products for the treatment of malaria, caused by clinically relevant Plasmodium species.

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