(Originally posted by the Northwest Association for Biomedical Research)On Tuesday, April 14, officials at the Food and Drug Administration issued a warning letter to Coast IRB in response to their recent approval of a fake device study submitted by the Government Accountability Office. As a result Coast IRB has voluntarily agreed to review no new studies or enroll new subjects into ongoing protocols, both under 21 CFR Part 56.
- FDA warning letter: http://www.fda.gov/foi/warning_letters/s7157c.pdf
- FDA press release: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01996.html