Rare Disease Report

Janet Woodcock - FDA and Gene Therapy

OCTOBER 23, 2016
Janet Woodcock, MD

In this exclusive interview with Rare Disease Report, Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) talks about the issues involved in getting gene therapy properly reviewed by the FDA. As Dr Woodcock points out, the concern is not assessing the efficacy of the therapy as much as the technical and manufacturing process.

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