Malaria: Developing Drugs for Treatment: Draft Guidance for Industry

Issue Date: September 23, 2025
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Draft

Malaria: Developing Drugs for Treatment: Draft Guidance for Industry

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Malaria: Developing Drugs for Treatment.” The purpose of this draft guidance is to assist sponsors in the overall development program for drug and biological products for the treatment of malaria, caused by clinically relevant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

Download the Guidance Document

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