JD Supra

FDA Clarifies ANDA Active Ingredient Sameness Evaluation In Draft Guidance

On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s ...
JD Supra

FDA draft guidance addresses complexities in establishing active ingredient sameness in an ANDA

The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA – Active Ingredients,” which aims to assist applicants preparing an abbreviated new ...