The U.S. FDA has shared information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies, with the goal of expediting product development.
“Regulatory flexibility must be tailored for cell and gene therapies,” said FDA Commissioner Marty Makary. “These are common-sense reforms that will address the unique characteristics of cell and gene therapies and foster more innovation.”
According to an FDA press release, while there is a long history of CBER making concerted efforts to help sponsors meet standards to assure product safety, purity and potency, the application of flexibilities has not always been fully clear to stakeholders.
The agency shared a bulleted list of flexibilities in clinical development, commercial specifications and process validation that it says will help sponsors understand what types of regulatory flexibility may be scientifically acceptable.
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