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# Guide on Epidermolysis Bullosa Drug Development
- URL: https://www.fdaweb.com/guide-on-epidermolysis-bullosa-drug-development/
- Published: 2018-06-15T12:00:00.000Z
- Updated: 2026-09-15T00:13:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141693

FDA has made available a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610678.pdf?ref=fdaweb.com) entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” The document focuses on drug development and trial design issues specific to treating EB, including FDA’s current thinking on endpoint considerations. It notes that there is “not yet sufficient clinical trial precedent to guide definitive endpoint advice,” adding that sponsors should meet with the appropriate review division in early planning stages for advice tailored to each drug development program.