> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Issues Guidance on Malaria Drug Development
- URL: https://www.fdaweb.com/fda-issues-guidance-on-malaria-drug-development/
- Published: 2025-09-22T12:00:00.000Z
- Updated: 2026-09-14T15:22:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159910

FDA has released a [draft guidance](https://www.fda.gov/media/188817/download?ref=fdaweb.com) entitled *Malaria: Developing Drugs for Treatment* that outlines key considerations for companies developing drugs to treat the tropical disease. The document is intended to help drugmakers design clinical trials for therapies targeting malaria caused by a range of *Plasmodium* species, including *P. falciparum*, the deadliest form, and *P. vivax*, which is responsible for recurring infections.

The agency stresses that the guidance applies specifically to treatments, not to malaria prevention or prophylaxis. It also does not cover other aspects of drug development such as pharmacology, toxicology, or manufacturing.

Among the recommendations, FDA emphasizes the use of active control regimens containing approved antimalarial drugs in clinical trials. Non-approved comparators may be acceptable if they reflect the local standard of care, but sponsors should consult with FDA in those cases. The agency said it will consider standards set by organizations such as the World Health Organization, the CDC, and the Infectious Diseases Society of America.

To reduce the risk of reinfection during studies, the agency recommends that trial participants either be monitored in hospital settings or protected using insecticide-treated bed nets. The guidance also underscores the importance of follow-up, noting that relapses or recrudescence can occur more than four weeks after treatment. Sponsors should consider extending follow-up visits to at least 42 days, particularly when testing drugs with long half-lives.