FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs.
One guidance, issued as final, focuses on how manufacturers should assess adhesive performance in TDS products, setting out specific evaluation criteria.
The second guidance, released as a draft, outlines recommended in-vivo methods for studying skin irritation and sensitization associated with these products.
Together, the guidances aim to harmonize testing approaches and help manufacturers demonstrate product safety and efficacy for generic TDS approvals.
This writeup was produced by pharmadog from original reporting by raps.
Original headline: “Expert sees shift to ‘ecosystem-centric assurance’ under FDA’s distributed manufacturing rule”
read at raps ↗
comments(0)
5-min edit window · permanent after that