Medical Journals and Other Articles 

(2021)

DTWG is providing access to certain public materials from other stakeholders as a convenience.  The inclusion of this material does not necessarily reflect the positions or views of DTWG or its members.

• The FDA’s Experience with Covid-19 Antibody Tests. New England Journal of Medicine. February 18, 2021. Jeffrey Shuren, M.D., J.D., and Timothy Stenzel, M.D., Ph.D. (HERE)
• A High-Level Overview of the Regulations Surrounding a Clinical Laboratory and Upcoming Regulatory Challenges for Laboratory Developed Tests.  Laboratory Medicine.  December 7, 2020 (HERE)
• Covid-19 Molecular Diagnostic Testing — Lessons Learned. New England Journal of Medicine. October 22, 2020. Jeffrey Shuren, M.D., J.D., and Timothy Stenzel, M.D., Ph.D. (HERE)
• The Validity of VALID Act: Cost Modeling Cancer Diagnostics Regulation By the FDA. American Society of Clinical Oncology Journal.  May 25, 2020 (HERE)
• Laboratory-Developed Tests: A Legislative and Regulatory Review.  Clinical Chemistry. October 1, 2017 (HERE)