CBER Sees Steady Increase In Emergency IND Requests – And A Big COVID Spike In FY 2020
Outside the pandemic, sponsor INDs for investigational cell and gene therapies appear to be driving much of the increase, and the surging growth continues to cause workload challenges for the US FDA.
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Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.
A growing focus on real-world evidence and an expected infusion of user fee funding are among the reasons for the new office branches at US FDA’s biologics center.
Office of Tissues and Advanced Therapies seeks to optimize its organizational structure and adopt more group-level communications, instead of one-on-one interactions with sponsors, to keep up with the massive growth in cell and gene therapies, director Wilson Bryan says.