A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
Chromosomal microarray analysis reveals many gene variants of unknown significance. The uncertainty about these variants—might they be deleterious or are they benign?—complicates genetic counseling.
Timothy K. Mackey, MAS and Bryan A. Liang, MD, JD, PhD
Studies show that clinical practice guidelines, used by an accused physician or by patients alleging a breach of standard care, have an impact on case outcomes.
In Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court ruled that synthetically created DNA is patentable, but the isolation of unaltered gene sequences is not.
AMA J Ethics. 2015;17(9):849-853. doi:
10.1001/journalofethics.2015.17.9.hlaw1-1509.