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GUIDANCE DOCUMENT

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment January 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-2315

Docket Number:
FDA-2022-D-2315
Issued by:
Guidance Issuing Office
Center 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).

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