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FDA Guidance Aims to Reduce Adhesion Failures of Generic Patches

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.

Manufacturers of transdermal patches should demonstrate that reasonable efforts were made to optimize the adhesive characteristics of the patch, said a new FDA draft guidance.

The guidance aims to help manufacturers design transdermal packages that effectively stick to the skin. It recommends ways to evaluate...

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