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Fast-Track Approval: Balancing Speed and Safety in Drug Approvals

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The FDA’s Fast Track approval program, designed to speed drug development for life-threatening conditions, has faced increased scrutiny over the years. I’ve mainly used Biogen’s controversial Alzheimer’s drug Aduhelm to shed light on the accelerated approval problems. However, the problems run deeper than Aduhelm.

In this article, I’ll highlight the FDA’s Fast Track approval program, dive into its fundamental problems, and discuss solutions to improve the much-needed program.

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