News and commentary about white-collar crime, enforcement, and compliance
Harry Cassin
Publisher and Editor
Andy Spalding
Senior Editor
Jessica Tillipman
Senior Editor
Bill Steinman
Senior Editor
Richard L. Cassin
Editor at Large
Elizabeth K. Spahn
Editor Emeritus
Cody Worthington
Contributing Editor
Julie DiMauro
Contributing Editor
Thomas Fox
Contributing Editor
Marc Alain Bohn
Contributing Editor
Bill Waite
Contributing Editor
Russell A. Stamets
Contributing Editor
Richard Bistrong
Contributing Editor
Eric Carlson
Contributing Editor
A recent judicial interpretation issued by China’s top judicial and prosecutorial bodies now criminalizes submitting falsified nonclinical study or clinical study reports and related materials. This could affect life sciences companies and contract research organizations operating in China.… Continue Reading
Late last week, the China Food & Drug Administration released for public comment four draft policy circulars designed to speed approvals for innovative drugs and medical devices, permit conditional approvals for certain products where efficacy has been proven in clinical trials, further protect data exclusivity during clinical trials, allow more flexibility during clinical trials, and clarify IP rights.… Continue Reading