FDA Guidance for Industry: Transdermal and Topical Delivery Systems - Product Development 1 and Quality Considerations

Title:
FDA Guidance for Industry: Transdermal and Topical Delivery Systems - Product Development 1 and Quality Considerations

https://www.gmp-compliance.org/files/guidemgr/1481899 DFT.pdf

Origin/Publisher:

FDA

Content:
This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS)2 regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

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