Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Residual Drug in Transdermal and Related Drug Delivery Systems." This draft guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and development--as well as during manufacturing and product lifecycle management--to ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The draft guidance is applicable to investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental new drug applications (sNDAs) for TDDS, TMDS, and topical patch products.