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# Draft Guide on Corticosteroid Products for Hemorrhoids
- URL: https://www.fdaweb.com/draft-guide-on-corticosteroid-products-for-hemorrhoids/
- Published: 2019-12-06T12:00:00.000Z
- Updated: 2026-09-14T15:55:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145671

FDA has released a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-locally-applied-corticosteroid-products-short-term-treatment-symptoms-associated?ref=fdaweb.com) entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.” The document is intended to assist sponsors in the clinical development of locally applied corticosteroid products (including suppositories or products that require an applicator) for the short-term treatment of symptoms associated with internal or external hemorrhoids. It describes FDA’s current thinking regarding the recommended attributes of patients for enrollment, efficacy assessments, and safety assessments. However, FDA says it does not address the clinical development of drugs for the chronic treatment of hemorrhoids.