ARTICLE | Regulation

Acting FDA Commissioner Woodcock defends aducanumab approval

Woodcock said she wasn’t involved in the decision, and that the data were ‘solid’

June 15, 2021 10:08 PM UTC

Acting FDA Commissioner Janet Woodcock strongly defended the agency’s accelerated approval of Biogen’s Aduhelm aducanumab Tuesday, in an interview with BioCentury.

Woodcock, who said she wasn’t personally involved in making the decision, said it fits squarely within the agency’s standards for accelerated approval. ...