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Zdrowie i gospodarka · 8.08.2019

Fabry Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Fabry Disease: Developing Drugs for Treatment." This draft guidance describes the Agency's current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints to be used in clinical development programs of investigational drugs to treat Fabry disease. Through this draft guidance, the Agency provides clear and specific guidance to foster greater efficiency in drug development in this rare disease with the goal of enhancing clinical trial data quality and supporting the development of treatments for Fabry disease.

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