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The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.
On Nov. 20, 2019, FDA published draft guidance recommending development and quality considerations for transdermal and topical delivery systems sponsors should include in new drug applications and abbreviated new drug applications. Specifically, the guidance describes recommendations for product design and pharmaceutical development, manufacturing process and control, and finished product control. Areas where quality is closely tied to product performance and safety (e.g., adhesion failure and impacts of applied heat) are also addressed.