federal_register: 2017-27156

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2017-27156 Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease."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. 2017-12-18 2017 12 https://www.federalregister.gov/documents/2017/12/18/2017-27156/developing-targeted-therapies-in-low-frequency-molecular-subsets-of-a-disease-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2017-12-18/pdf/2017-27156.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease."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...  

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