FDA Issues Draft Guidance for Developing Hemorrhoids Treatments

The FDA has recommended using increased patient input in a new draft guidance on developing corticosteroid hemorrhoid treatments.

The guidance calls on sponsors to select patient-reported outcome (PRO) instruments that will measure what patients say are their most troublesome symptoms. The FDA encouraged sponsors to use existing PRO instruments rather than develop new ones.

Comments on the draft guidance are due by Feb. 7, 2020.