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# Lyme Disease Drug Development Guidance
- URL: https://www.fdaweb.com/lyme-disease-drug-development-guidance/
- Published: 2023-02-01T12:00:00.000Z
- Updated: 2026-09-14T18:14:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153677

FDA has published a draft guidance, *Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment*, with the agency’s current recommendations about developing drugs to support an indication for treating early Lyme disease as manifested by erythema migrans. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/early-lyme-disease-manifested-erythema-migrans-developing-drugs-treatment?ref=fdaweb.com) does not contain a discussion of the general issues of statistical analysis or clinical trial design, which are addressed in three International Council for Harmonization guidelines.

The guidance also does not discuss general considerations (e.g., pharmacology/toxicology or clinical pharmacology) of drug development because these considerations are similar to those for other indications for anti-infective drugs.