23 Sep 2025
💊FDA Releases Draft Guidance for Malaria Drug Development
Malaria: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Malaria: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the overall development program for drug and biological products for the treatment of malaria, caused by clinically relevant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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance from the FDA regarding malaria drug development has direct implications for pharmaceutical businesses. It outlines regulatory requirements for drug development and invites comments, potentially affecting future compliance and operational strategies. Additionally, it emphasizes considerations for cost savings, impacting financial planning.