Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment January 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to provide the Food and Drug Administration’s (FDA’s) current 17 recommendations regarding the development of drugs to support an indication for the treatment 18 of early Lyme disease as manifested by erythema migrans (EM).