Clinical-stage pharmaceutical, biotechnology and medical device companies need to generate “buzz” in order to attract investments to fund the costly clinical studies required for marketing approval.
In part one of this series, I covered how FDA regulations prohibit companies from promoting an investigational drug or device. In this post, I’ll discuss the securities regulations that forbid companies from making untrue statements or omitting material facts. Recall from part one of this series that violations of FDA regulations and securities regulations can result in lawsuits, FDA response, fines, injunctions, consent decrees and criminal actions. Working with legal counsel to implement appropriate compliance measures and to review statements regarding pipeline products and clinical trial results will help to manage such risks. But, at the very least, all company personnel should be familiar with the laws and regulations discussed in this series of posts. Read full article here.
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