Issue Date: June 26, 2025
Issued by: Center for Drug Evaluation and Research
Topic(s): Pediatric Product Development, Clinical – Antimicrobial
Status: Final
Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment
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 This guidance finalizes the draft guidance of the same name issued on February 1, 2023.
Download the Guidance Document
