Monthly Archives: October 2009

Busy Busy US Attorneys

Posted on October 14, 2009 by Mark Senak

There has either been an increase in the number of announcements by US Attorneys offices around the country, meaning they have just discovered the press release, or there is an unusual amount of criminal roundups affecting medical products.  Let's review … Continue reading →

Posted in Uncategorized | 1 Comment

The CEI Report on the FDA and Internet Advertising – Raising Essential Questions

Posted on October 13, 2009 by Mark Senak

The news that the FDA is planning to hold a Part 15 meeting on social media is almost universally welcomed by those involved in marketing and communications related to medical products.  For far too long, the FDA has dragged its … Continue reading →

Posted in FDA Policy, New and Social Media | Comments Off on The CEI Report on the FDA and Internet Advertising – Raising Essential Questions

Eye on FDA Goes Kindle!

Posted on October 12, 2009 by Mark Senak

If you are Kindle-bound, as I am, Amazon is now carrying Eye on FDA so that one can subscribe on Kindle!  

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Upcoming Speaking Gig

Posted on October 12, 2009 by Mark Senak

I am speaking at Digital Pharma, Oct 19-21, Bridgewater, NJ. Use discount code P615SPK to register at http://is.gd/3J34I

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A Bitter Pill to Swallow – The Perils in Off Label Promotion

Posted on October 9, 2009 by Mark Senak

On September 29, the US. Attorney's Office for the Northern District of California announced that a former CEO of InterMune was convicted of wire fraud for the "creation and dissemination of false and misleading information about the efficacy of InterMune's … Continue reading →

Posted in Regulatory Communications | 3 Comments