Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Grant funding available through FDA’s Orphan Products Office. The latest on CDRH’s whistleblower email surveillance investigation. More regulatory news.
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Pressure Mounts On FDA After Public Release Of Surveillance Documents
Multiple investigations and lawsuits have opened in response to the matter, with more potentially to come. Some worry the intensifying issue has serious implications for the quality of the device center’s output.
Regulatory News In Brief
President Obama signs FDA user fee bill. FDA issues rules requiring PMAs for two pre-amendment devices. More regulatory news.
CDRH Spyware Suit: Whistleblowers Sue Agency Over Email Surveillance
Six current and former employees of FDA’s device center file suit in the U.S. District Court in Washington, D.C., arguing that email and computer surveillance violated their constitutional and legal whistleblower rights.