FDA Publishes Draft Guidance Concerning Sameness in ANDAs

FDA published a draft guidance concerning sameness evaluations in abbreviated new drug applications (ANDAs) on Nov. 8, 2022. The guidance discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

In addition to general recommendations on demonstrating sameness, the guidance provides additional considerations for products like synthetic peptides and complex mixtures. The guidance also provides non-binding examples of active ingredient characterization in the drug product.

The draft guidance can be viewed in full here. FDA is soliciting comments on the guidance through Jan. 8, 2022.