The final guidance provides specific instructions regarding study design, scoring systems, and data analysis to assess adhesion performance in transdermal and topical delivery systems, which replaces previous draft guidance from April 2023.
Adhesion failures can lead to improper dosing or accidental exposure, impacting patient safety. This guidance ensures that generic products meet specific safety standards and maintain proper functionality throughout their wear period.
Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.
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Review in the next regulatory intelligence cycle.
Standardized adhesion scoring system, expectations for study duration, and requirements for analyzing and reporting adhesion data to demonstrate similarity to the reference product.
MAHs should ensure that post-market safety surveillance and signal management processes include monitoring for adhesion-related reports, as these can be indicators of product quality issues or safety risks (e.g. unintended exposure to others). Clinical teams must use the finalized scoring system for new study submissions.
Requires applicants to design studies according to new standards for adhesion performance
New guidance on evaluating TDS adhesion
Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.
This final guidance outlines clinical expectations for assessing the adhesion of transdermal and topical delivery systems (TDS) in support of ANDAs, emphasizing a standardized scoring system and monitoring for adhesion-related reports.
What changed: The final guidance provides specific instructions regarding study design, scoring systems, and data analysis to assess adhesion performance in transdermal and topical delivery systems, which replaces previous draft guidance from April 2023.
Why it matters: Adhesion failures can lead to improper dosing or accidental exposure, impacting patient safety. This guidance ensures that generic products meet specific safety standards and maintain proper functionality throughout their wear period.
Practical implication: Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.
Published from the Firecrawl policy change extraction pipeline.
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