Life Science Compliance Update

July

2016

Unlikely Bedfellows: SEC Penalties When Industry Fails to Disclose FDA Recommendations for Clinical Trials

Written by , Posted in Enforcement

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In a unique case, the U.S. Securities and Exchange Commission (SEC) recently announced a significant settlement with AVEO Pharmaceuticals for failing to disclose publicly as part of its quarterly financial filings that the FDA had recommended a second round of clinical trials for kidney cancer drug, Tivozanib, as part of the drug approval process. This case represents a new chapter in SEC regulatory oversight involving the life sciences industry when there are omissions, failure to disclose, and other transparency issues involving a company’s SEC filings.


 To purchase the complete July 2016 issue of LSCU, Click here.

Topic tags:

Gravityscan Badge
Menu Title