FDA Guidance Aims to Reduce Adhesion Failures of Generic Patches
This article was originally published in The Gold Sheet
FDA aims to help manufacturers improve the adhesive qualities of transdermal patches in a new guidance. Agency official says that poor adhesion is a major quality problem with these patches and has been the source of numerous recalls.
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FDA’s draft guidance on transdermal and topical delivery systems says manufacturers can leverage pharmaceutical development studies principles for device design control requirements.
Complex Generics: US FDA Heeds Some, But Not All, Of Industry’s Calls For Flexibility On Transdermal Products
Revised draft guidance suggests greater openness to alternative methods and scales for measuring adhesion, but agency sticks with 15% non-inferiority margin despite manufacturer objections; FDA also releases new guidance on assessing irritation and sensitization potential with topical delivery system products.
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