FDA Tells Generic Cream Makers How to Test Skin
Published Date: 7/14/2026
Notice
Summary
The FDA just released new rules for companies making generic skin creams with steroids. These rules explain how to prove their products work just as well as the original ones by testing on real people’s skin. This update affects drug makers and helps speed up safe, affordable medicine options starting now.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
ANDA Guidance for Topical Steroids
The FDA issued final guidance on July 14, 2026, giving recommendations to applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroids of all potency groups. The guidance describes an in vivo pharmacodynamic approach to demonstrate bioequivalence, including recommendations for pilot dose duration vasoconstrictor response and pivotal vasoconstrictor bioequivalence studies.
Study Subject Qualifications Clarified
The final guidance clarifies that subjects used for chromameter and operator qualification may differ from those enrolled in the pilot dose duration vasoconstrictor response and pivotal vasoconstrictor bioequivalence studies. The guidance also adds a history of hypopigmentation as a subject exclusion criterion.
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