FDA officials, experts discuss impact of Covid-19 on cell and gene therapies
While the FDA is still receiving investigational new drug applications (INDs) for cell and gene therapies, officials are concerned about the impact of the Covid-19 pandemic on clinical trials.
“It’s clear that COVID-19 has adversely affected all aspects of development of cell and gene therapies,” said CBER director Peter Marks at the Alliance for Regenerative Medicine’s Meeting on the Mesa. “For some of the studies that are ongoing there are some real challenges to overcome in terms of endpoints that may have been missed.”
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