Thousands of gene and cell therapies are inundating FDA reviewers as the agency tries to keep up
The FDA’s staff is flooded with thousands of cell and gene therapy trials making their way through a short-handed regulatory workforce.
While the FDA has plans to add to its ranks of reviewers, it could take years before its capabilities catch up to the biotech industry’s pipeline. There are more than 2,500 cell and gene therapy trials underway, with the bulk of those added from 2016 to 2020, according to FDA officials. The huge number of programs, combined with an understaffed agency, are likely to result in delays in the review of trials and applications, more caution and clinical holds from the agency, and in some cases more time needed for successful treatments to reach patients.
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