FDA releases guidance for new Alzheimer’s drugs

“This draft guidance is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public,” said Dr. Russell Katz, the director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to vigorously addressing Alzheimer’s disease and will work with industry to help develop new treatments in this early population as expeditiously as possible.”


Clinical trials and studies are recommended, the FDA says, to detect the onset of Alzheimer’s disease. The agency is looking for public comment on ways to proceed with drug and treatment development, with comments due by April 7.