ARTICLES BY KATE COOK
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![Surveying]( "Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies")
Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies8/15/2018The FDA has been issuing guidance documents addressing gene therapy development issues for approximately 20 years — a remarkable dedication of resources to an area that did not have a licensed product until 2017. Of the six gene therapy-related draft guidances the agency issued last month, two represent the first of the “suite of disease-specific guidance documents on the development of specific gene therapy products” Commissioner Scott Gottlieb promised in Dec. 2017.
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![FDA Sign]( "FDA’s New Guidance On CMC For Gene Therapy INDs — What You Need To Know")
FDA’s New Guidance On CMC For Gene Therapy INDs — What You Need To Know7/23/2018The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy.
Kate Cook
Kate Cook is executive VP of drug and biological products at Greenleaf Health, Inc. She joined Greenleaf after a long career at the FDA, including 15 years in the Office of Chief Counsel, five years in the Office of the Center Director at the FDA’s Center for Biologics Evaluation and Research, and one and a half as associate director for regulations and policy at the FDA’s Center for Devices and Radiological Health. You can contact her at kate.cook@greenleafhealthllc.com.