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Complex Generics: US FDA Heeds Some, But Not All, Of Industry’s Calls For Flexibility On Transdermal Products

 
• By Sue Sutter

Revised draft guidance suggests greater openness to alternative methods and scales for measuring adhesion, but agency sticks with 15% non-inferiority margin despite manufacturer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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The US FDA’s revised guidance on assessing adhesion with transdermal and topical delivery system (TDS) generic drugs reflects the agency’s receptivity to some, but not, all of industry’s criticisms that a June 2016 draft document would be too burdensome for manufacturers.

A revised draft guidance released Oct. 9 suggests a greater openness to the use of alternative methods and scales...

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