Workweek January 7, 2023
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.
THE DEETS
The FDA created the Fast Track program in 1992 to speed drug development to treat life-threatening diseases like HIV and cancer. The traditional drug pathway may take around 15 years to bring a drug from research and development to market, no matter how beneficial the drug may be as evidenced...
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