26 Jun 2025
💊FDA Guidance on Developing Drugs for Early Lyme Disease Treatment
Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of early Lyme disease as manifested by erythema migrans (EM). This guidance finalizes the draft guidance of the same name issued on February 1, 2023.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document provides guidance on developing drugs for early Lyme disease, impacting pharmaceutical companies and sponsors in compliance and drug development processes. Executives need to consider this guidance for regulatory adherence in their clinical trials.