FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: EARLY LYME DISEASE AS MANIFESTED BY ERYTHEMA MIGRANS: DEVELOPING DRUGS FOR TREATMENT; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, June 26 -- Food and Drug Administration has issued a notice called: Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Guidance for Industry; Availability.

The notice was published in the Federal Register on June 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 g...