ARTICLES BY KATIE MCCARTHY
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![Summarizing FDA’s New Guidance On Gene Therapy For Hemophilia]( "Summarizing FDA's New Guidance On Gene Therapy For Hemophilia")
Summarizing FDA's New Guidance On Gene Therapy For Hemophilia8/3/2018The FDA recently issued six draft guidance documents. This article discusses the guidance Human Gene Therapy for Hemophilia.
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![FDA’s New Guidance On Gene Therapy For Retinal Disorders — A Primer]( "FDA's New Guidance On Gene Therapy For Retinal Disorders — A Primer")
FDA's New Guidance On Gene Therapy For Retinal Disorders — A Primer8/2/2018This is the fifth article in a six-part series summarizing each of the FDA's gene therapy draft guidance documents. It will discuss the draft guidance Human Gene Therapy for Retinal Disorders.
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![rare-disease]( "Human Gene Therapy For Rare Disease — Examining FDA's New Draft Guidance")
Human Gene Therapy For Rare Disease — Examining FDA's New Draft Guidance7/30/2018The FDA recently issued for public comment six draft guidance documents. This is the fourth article in a series and will discuss the guidance Human Gene Therapy for Rare Disease.
Katie McCarthy
Katie McCarthy is VP of regulatory affairs in the Drug and Biological Products group at Greenleaf Health, Inc. She specializes in scientific and regulatory issues affecting pharmaceutical and biotechnology companies. You can reach her at katie.mccarthy@greenleafhealthllc.com.