FDA (CDER)
GUIDANCE DRAFT
Malaria: Developing Drugs for Treatment: Draft Guidance for Industry
Published: 9/23/2025Detected: 3/20/2026
Summary preview
Sets out FDA’s draft approach for developing malaria drugs intended to treat patients, including expectations for clinical evidence generation.
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clinical
safety
labeling
quality
manufacturing
#malaria
#treatment
#drug development
#clinical trials
#endpoints
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