Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids

On 6 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 7 February 2020.

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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