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August 20, 2018 5:00 pm

Comment Deadline: FDA Major Depressive Disorder — Developing Drugs for Treatment (Draft Guidance)

  • Government
  • Agency
  • Neuroscience

The Food and Drug Administration (FDA) is seeking public comment on a draft guidance for industry titled "Major Depressive Disorder: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder. Specifically, this draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. This draft guidance is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. This guidance revises the guidance for industry entitled “Guidelines for the Clinical Evaluation of Antidepressant Drugs” issued in September 1977.

Members of the public may submit comments by mail or at Regulations.gov. More information is available at this Federal Register notice.