The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies.
The agency said the approach is meant to expedite development of complex biologics without compromising safety, purity or potency, according to a Jan. 11 news release. The FDA’s Center for Biologics Evaluation and Research has approved nearly 50 such therapies over the past decade.
FDA Commissioner Marty Makary, MD, called the changes “common-sense reforms” tailored to the unique characteristics of cell and gene products. CBER officials said the agency is now communicating these flexibilities more broadly to ensure consistency across review teams and help developers better understand what may be scientifically acceptable.
The FDA said it will continue emphasizing product quality while working to reduce perceived regulatory barriers in preparation for Biologics License Application submissions.
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