FDA acting commissioner Janet Woodcock acknowledged in a letter to Christi A. Grimm, the acting inspector general of the Department of Health and Human Services, that there has been “significant attention and controversy” surrounding the approval of Aduhelm, which is manufactured by Biogen, a Cambridge, Mass., biotech company. In particular, she said, concerns continue to be raised about the agency’s contacts with Biogen, including “some that may have occurred outside of the formal correspondence process.”

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