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# Concerns With Alzheimer’s Drug Development Guidance
- URL: https://www.fdaweb.com/concerns-with-alzheimers-drug-development-guidance/
- Published: 2024-06-11T12:00:00.000Z
- Updated: 2026-09-14T14:32:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157156

Biogen praises an FDA draft guidance on developing drugs to treat early Alzheimer’s disease and [offers](6-11-24%20OPQ.docx) one comment on the diagnostic criteria for early Alzheimer’s and two comments on outcome measures. The company also provides line-by-line specific technical comments.

In its [response](https://www.regulations.gov/comment/FDA-2013-D-0077-0088?ref=fdaweb.com), Public Citizen says that while it agrees with the need for research to develop new treatments and diagnostic tools for early Alzheiner’s, the draft raises three main areas of concern:

- the proposed definition of early Alzheimer’s and the reliance on biomarkers are both a diagnostic tool and a measure of benefit;
- the proposed criteria for the duration of clinical trials and the selection of clinical endpoints; and
- insufficient guidance for the development of drugs for early Alzheimer’s disease.

“We urge FDA to revise the final guidance to fully address these concerns,” the advocacy group says.