Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
CDRH scientists under investigation?: The nine CDRH staffers who charge that device center managers coerced reviewers into modifying scientific evaluations and recommendations may themselves be subject to a criminal investigation, according to a Jan. 28 report in the New York Times. The story cites a letter the staffers reportedly sent to President Barack Obama on Jan. 26, alleging that FDA management may have recently ordered the FDA Office of Criminal Investigations to investigate them. The group previously sent letters to Congress and to Obama's transition team alleging wrongdoing in the center (1"The Gray Sheet" Jan. 12, 2009, p. 7)