Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability; Reopening of the Comment Period

Issuing agencies

Abstract

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability that published in the Federal Register of June 8, 2023. In that notice, FDA requested comments on the draft guidance for industry (GFI) #279 entitled "Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to develop and submit comments.