WINSTON-SALEM, NC - Advances in technology often outpace the ability of regulatory bodies to keep up with the latest breakthroughs. When products regulated by the Food and Drug Administration (FDA) are involved, product manufacturers can struggle to find the appropriate regulatory pathways for evolving technologies.

Womble Bond Dickinson Regulatory Scientist Heather Hatcher, Ph.D., has co-authored a recent article on regulatory science issues surrounding the FDA-regulated additive manufacturing (or 3D printing) of medical products. The article was published online November 29, 2018 in the Journal of Clinical and Translational Science.

The article stems from a discussion at the 2017 Fall Forum of the Regulatory Science to Advance Precision Medicine Working Group in Washington, DC.

Co-authors of this article with Dr. Hatcher included Joan Amado and Scott Steele of the University of Rochester Medical Center’s Clinical & Translational Science Institute; Warren Grayson of the Translational Tissue Engineering Center at the Johns Hopkins University School of Medicine; Jennifer Swanton Brown of the Stanford Center for Clinical & Translational Research & Education; Andrika Thomas of Weill Cornell Medicine’s Core Laboratory of the Clinical & Translational Science Center; and Scott Hollister of the Center for 3D Medical Fabrication and Department of Biomedical Engineering at the Georgia Institute of Technology/Emory University.

Click here to download and read “ Regulatory Interfaces Surrounding the Growing Field of Additive Manufacturing of Medical Devices and Biologic Products”.

Heather Hatcher, Ph.D., is a regulatory scientist with the Womble Bond Dickinson Regulatory Affairs Advance Service Team. Drawing on her background as a research scientist, Dr. Hatcher provides strategic regulatory guidance to clients in the pharmaceutical and medical device industries.


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