Regulatory Blog

Introduction This guidance, "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs ", published in March 2026 , provides detailed recommendations for applicants submitting Abbreviated New Drug Applications (ANDAs) for topical drug products. It focuses on physicochemical and structural (Q3) characterization, which plays a critical role in demonstrating product performance and bioequivalence (BE). Topical products, especially semisoli

Yesterday (October 21, 2022) USFDA Released multiple New draft guidelines providing guidance on topical generic drug product...