FDA Announces Availability of Draft Guidance – Transdermal and Topical Delivery Systems – Product Development and Quality Considerations

FDA Announces Availability of Draft Guidance – Transdermal and Topical Delivery Systems – Product Development and Quality Considerations

FDA announced today the availability of a draft guidance for industry entitled "Transdermal and Topical Delivery Systems – Product Development and Quality Considerations." This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, the guidance discusses FDA’s current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery.

Transdermal delivery systems are designed to deliver an active ingredient (drug substance) across the skin and into systemic circulation, while topical delivery systems are designed to deliver the active ingredient to local tissue. Both delivery systems present similar manufacturing and quality control concerns and similar risks to patients. This guidance is intended to provide clear and detailed recommendations to applicants and manufacturers of TDS products regarding issues that have been the subject of industry questions. These recommendations can help reduce the approval cycle for TDS by clarifying the quality expectations for this type of dosage form.

This draft guidance supports our Drug Competition Action Plan to promote the efficiency and effectiveness of the application assessment process.

Comments or suggestions regarding this draft guidance can be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Written comments can be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA-2019-D-4447.