IN3 Webinar
“Capitalizing
on Current FDA Guidance: The Promise and Perils of Disseminating
Scientific Literature about Off-Label Use of Medical Devices”
Thursday, February 11, 2010, 2:00-3:30 p.m. EST/11:00 a.m.-12:30 p.m. Pacific
If
you’re a device manufacturer, it’s critical that you follow FDA’s
January 2009 guidance on disseminating scientific literature about
off-label use. Under the guidance, FDA allows device companies to
disseminate articles to doctors if their research is peer-reviewed and
published in a journal that has an expert editorial board.
To
get the information you need to capitalize on this new guidance and on
recent trends in regulatory action, join us for this exciting new
webinar. You’ll also find out what steps you can take to avoid the
still-substantial risks from government scrutiny into potentially
improper off-label promotion of these devices.
Here’s just some of what you’ll learn when you participate in this comprehensive 90-minute webinar:
•How the FDA’s new guidance
on the dissemination of literature for off-label uses will impact both
your everyday as well as your strategic-business operations.
•Insights into the risks
device manufacturers continue to face from accusations of improper
off-label promotion by the FDA and DOJ—risks that remain significant
even under the new guidance.
•Current status of the laws regulating off-label use promotions.
•Recent enforcement activity, especially in the context of your day-to-day operations.
•How to position your device company to take full advantage of potential opportunities that result from this new FDA guidance.
Take
advantage of this opportunity to train your entire team on the
potential problems and opportunities of the new FDA guidance for
off-label device use when you register today for this new IN3 webinar.
For more information about this Webinar, please visit
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