The American Journal of Bioethics 10(9):35-45 2010, By Laurence B. McCullough, Robert Brent, Frank A. Chervenak, Benjamin Hippen, 3 September 2010
“On February 3, 2010, a Letter of Concern from Bioethicists, organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments.”
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