FDA Modernizing Evaluations as Gene, Cell Therapy Fields Grow

Thursday, September 7, 2017

Food and Drug Administration commissioner Scott Gottlieb said the FDA is hurrying to modernize the way it evaluates a flood of new drug applications derived from the fast-growing fields of gene and cell therapy.

In a talk Thursday before a coalition of corporate and academic research entities, Dr. Gottlieb announced steps the agency will take to begin to grapple with the new science. For one thing, he said, the FDA will focus on conducting early scientific conversations with startup and small biotechnology companies.

He said they "sometimes don't have a full understanding of what it will take to get" applications filed and approved. "It's often the smaller companies or individual researchers who are working with the most novel technology platforms," he said.

Dr. Gottlieb estimated that the agency already has at least 626 active investigational new-drug applications related to gene and cell-therapy products.

"A lot of our policies, and yes, our regulatory framework, are fashioned to a much different paradigm of science and drug development," the commissioner said. "So we're challenged to adapt those policies."

"Our ability to fully capitalize on new science, and maintain FDA's gold standard for product review means FDA also needs to modernize itself alongside the new platforms that we're evaluating," Dr. Gottlieb said.

https://www.wsj.com/articles/fda-modernizing-evaluations-as-gene-cell-therapy-fields-grow-1504802513 (subscription only)

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