Zdrowie i gospodarka · 18.12.2017
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease." The purpose of this guidance is to describe the FDA's current recommendations on how to group patients with different molecular alterations for eligibility in clinical trials; and general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies.