Aduhelm Invades Senate Committee’s COVID-19 Hearing
Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.
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Reimbursement, health policy and medical experts predicted a slow rollout ahead for Biogen's new Alzheimer's treatment at a public meeting sponsored by ICER.
Acting US FDA Commissioner says it is standard for the Office of Neuroscience to issue broad labels like the one originally granted to Biogen’s new Alzheimer’s drug, but the agency declined to answer follow-up questions on such a policy. Woodcock continued to defend Aduhelm’s accelerated approval but conceded that the process might have been improved in an unusually tense public appearance.
US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.