FDA Faulted for Inappropriate Collaboration With Drug Company Before Approving Alzheimer's Drug

• After major pushback, the FDA approved Biogen's $56,000 drug, Aduhelm, in 2021.

• The 18-month investigation found that the FDA and Biogen had an "atypical" number of meetings.

"The committee also found that the agency and the company worked closely on a document prepared for outside advisers—so closely that at least one paragraph of Biogen’s submission was written by FDA officials."

Article: https://www.wsj.com/articles/biogen-aduhelm-fda-approval-congressional-investigation-11672333482

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