Julie Tibbets and Matt Mamak were featured speakers during this webinar program hosted by FDANews. When your company has a product in development, whether drug, device or biotech, what you can — and can’t — say about it is tightly regulated by the FDA. At the same time, the SEC requires that information of material value to investors be properly disclosed to them. Of course, this SEC requirement involves exactly the same products you have in your pipeline, the ones that the FDA wants you to be very careful about discussing.
How do you balance these seemingly contradictory demands?
And further, how do you correctly use all the forms of “communication” available today, including tweets, talking points, press releases, presentations to investors and even "likes" on Facebook?
Julie and Matt discussed and commented on the tricky issues surrounding the laws and regulations the FDA and SEC must enforce. Participants gained a fuller understanding of what exactly the responsibilities are and how to execute them without making mistakes that could damage a company's reputation and bottom line.
The following topics were covered during the program:
- 6 dos and 6 don’ts for speaking publicly about a product in development
- 4 dos and 3 don’ts when talking with analysts and investors
- Examples from case studies about communication that resulted in FDA enforcement actions, SEC penalties and investor lawsuits
For more information, please click here.
August 18, 2015