ARTICLES BY KATE COOK

  • How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA
    How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA

    On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.

  • FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say
    FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say

    Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.”  The document describes what a combination product is and how to interact with the FDA when developing a combination product, and it identifies some of the principles the agency uses in determining what type of premarket submission should be made. 

  • Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies
    Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies

    The 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. 

  • 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 Know

    The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy.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

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.