Zdrowie i gospodarka · 16.12.2008
Guidance for Industry on Orally Disintegrating Tablets; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Orally Disintegrating Tablets." The guidance provides pharmaceutical manufacturers of new and generic products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate proposed products as ODTs.