Becker's Healthcare January 10, 2023
The FDA is increasingly hesitant on allowing drugmakers to test their cell and gene therapy candidates in human trials, The Wall Street Journal reported Jan. 10.
Compared to 2012 through 2016, when each year saw human trial requests for experimental drugs denied 557 times on average, trials were paused 664 times each year from 2017 to 2021. From 2021 through December 2022, the FDA put 747 requests on hold, according to the Journal’s investigation.
One reason for the agency’s aversion...
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