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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Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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.

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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

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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.

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