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# Advancing Cell and Gene Therapy Development
- URL: https://www.fdaweb.com/advancing-cell-and-gene-therapy-development/
- Published: 2019-01-15T12:00:00.000Z
- Updated: 2026-09-15T00:54:29.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143152

FDA commissioner **Scott Gottlieb** and CBER director **Peter Marks** say the agency is seeing a surge in cell and gene therapy products entering early development, as shown by the large upswing in the number of IND applications. In a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629493.htm?ref=fdaweb.com), the two project that by 2020 the agency will receive more than 200 INDs yearly, building on the total of more than 800 active cell-based or directly administered gene therapy INDs currently on file.

“By 2025,” they write, “we predict that FDA will be approving 10 to 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rate of these products.”

Gottlieb and Marks say they are working to expand the review group dedicated to evaluating these applications and eventually want to add about 50 clinical reviewers to the group charged with overseeing the clinical investigation, development, and review of the products.

The statement also describes several new guidance documents FDA wants to incorporate.

“We believe these cell-based and gene therapy technologies hold tremendous promise for addressing some of the most intractable diseases,” the post concludes. “But with their novelty also comes new uncertainties and some unique, theoretical risks. Our efforts are aimed at helping innovators proactively address these potential risks, while we outline a modern and efficient pathway for the continued development of these innovations.”