Webinar November 9, 2015

Talking About Your Product Pipeline: FDA and SEC Considerations

Event Detail
Matthew W. Mamak
November 9, 2015


Alston & Bird hosted this webinar program on Monday, November 9, 2015. 

When your company has a product in development, whether drug, biologic, device or diagnostic, what you can — and can’t — say about it is tightly regulated by the FDA. At the same time, the SEC requires public companies to disclose information of material value to investors. Of course, this SEC requirement involves exactly the same products you have in your pipeline, the ones that the FDA requires you to be very careful about discussing.

How should companies balance these seemingly contradictory demands while still getting information about their pipelines out to the patient, medical and investor communities?

During this webinar, we discussed how companies, whether clinical-stage startups or well-established commercial businesses, can manage their FDA and SEC compliance obligations most effectively.

Julie Tibbets and Matthew Mamak provided specifics that help you navigate your way through these regulatory waters: 

  • An overview of FDA and SEC regulatory considerations for pipeline product communications 
  • Best practices for speaking publicly about products in development 
  • Best practices for talking with analysts and investors 
  • Case studies where product pipeline communications resulted in FDA enforcement actions, SEC penalties or investor lawsuits

QUESTIONS: Please contact Abby Forness at abby.forness@alston.com or call 404.881.7824.

This webinar was provided as a complimentary service to clients and friends of Alston & Bird.

November 9, 2015
1:00pm-2:30pm EST

Meet The Speakers
Media Contacts
Nicholas Clarke
Senior Communications Manager
Phone: 212.210.1222
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