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Notice2023-02103

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
February 1, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of early Lyme disease as manifested by erythema migrans (EM).

View on FederalRegister.gov →Plain-text source
Indexed from Federal Register on February 1, 2023.

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