In May of this year, the US Supreme Court handed down a unanimous decision that linked adverse reporting to the FDA with financial reporting. Matrixx had information concerning potential problems with Zicam Cold Remedy, the largest selling product in their line. They didn’t reveal the adverse event information to investors because they didn’t find the information statistically significant. The Court concluded that statistical significance is not the threshold for reporting.
The article, published in Cerulean’s Smarter Compliance™ is available in the Ombu Library. This newsletter is a valuable resource for people involved FDA regulatory issues. I recommend that readers subscribe to this valuable newsletter. To subscribe, send an e-mail to orders@ceruleanllc.com or visit www.ceruleanllc.com.
Readers may recognize Cerulean by its association with John Avellanet and his influential book Get To Market Now! This book, describing the methods you need to help turn FDA compliance into a competitive edge, belongs in the “most frequently read” section of your book shelf.