FDA Releases Guidance on Topical Patches

On May 31, 2016, FDA issued draft guidance on recommendations for designing and performing studies to evaluate adhesive performance in transdermal delivery systems or topical patches submitted with an abbreviated new drug application (ANDA). The draft guidance addresses the agency’s thinking in regards to adhesion scoring systems; adhesion studies including study design, study conduct, and statistical analysis; adhesion and bioequivalence; and formatting data submission.

FDA states that the new draft guidance supersedes “recommendations related to adhesion studies provided in individual product-specific guidances published prior to the date of publication of this guidance.”