Zdrowie i gospodarka · 18/03/2026

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications; Guidance for Industry, Availability

The FDA has released a final guidance for industry on the physicochemical and structural characterization of topical drug products submitted in Abbreviated New Drug Applications (ANDAs). The guidance aims to assist applicants in identifying the dosage form and describing properties critical to the product's performance.