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Zdrowie i gospodarka · 09/04/2007

Draft Guidance for Industry on Orally Disintegrating Tablets; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Orally Disintegrating Tablets." The draft guidance provides pharmaceutical manufacturers of new and generic drug products with an agency perspective on the definition of an orally disintegrating tablet (ODT)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 a proposed product as an ODT.

Source: Federal Register — Food and Drug AdministrationOpen original release →