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February 16, 2018 5:00 pm

Comment Deadline: FDA Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

  • Government
  • Agency
  • Genetics/Genomics

The Food and Drug Administration (FDA) is announcing the availability of and soliciting public comments on a draft guidance for industry entitled “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.”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.

Members of the public may submit comments at Regulations.gov or via the Postal Service. More information is available via the Federal Register notice.