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GUIDANCE DOCUMENT

Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry Draft Guidance for Industry December 2019

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-4433
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is 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. Specifically, this guidance describes FDA’s current thinking regarding the recommended attributes of patients for enrollment, efficacy assessments, and safety assessments.

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All written comments should be identified with this document's docket number: FDA-2019-D-4433.

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