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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Determinations Related to Allegations Regarding Dexamethasone Use in Pregnant Women

Sep 3, 2010 at 6:44am

The Office for Human Research Protections (OHRP) posted on its website OHRP's September 2, 2010 letter of determination along with a U.S. Food and Drug Administration (FDA) memorandum. OHRP received allegations concerning activities conducted by Dr. Maria New at Weill Cornell Medical College and Mount Sinai School of Medicine involving the use of dexamethasone in pregnant women at risk of carrying a female fetus with congenital adrenal hyperplasia.

During OHRP's review, OHRP had numerous discussions with staff at FDA, and determined that the allegations raised by the complainants are unproven and did not find any evidence that Dr. Maria New violated the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR Part 46).

See the letter here: http://www.hhs.gov/ohrp/detrm_letrs/YR10/sep10a.pdf