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User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals

Executive Summary

Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.

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June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.

Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval

June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.

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