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May 17, 2018 5:00 pm

Comment Deadline: FDA Early Alzheimer's Disease – Developing Drugs for Treatment (Draft Guidance)

  • Government
  • Agency
  • Industry
  • Neuroscience

The Food and Drug Administration (FDA) is seeking public comment on a draft guidance for industry titled "Early Alzheimer's Disease: Developing Drugs for Treatment". This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This guidance revises the draft guidance for industry entitled “Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease” issued February 8, 2013. This revision addresses FDA's current thinking regarding the selection of patients with early AD for enrollment into clinical trials and the selection of endpoints for clinical trials in these populations.

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