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Zdrowie i gospodarka · 23/08/2018

Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment." The purpose of this draft guidance is to assist sponsors who are developing drugs, devices, or biological products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA). This draft guidance does not address improvement of symptoms of OA, such as pain or functional impairment, which will be addressed in future guidances.

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