Monthly Archives: August 2013

OPDP Letters for Promotion of Investigational Compounds, Part 2

Posted on August 20, 2013 by Mark Senak

In my last posting, I provided an overview from my database of Warning and Untitled (NOV) letters data base that spans the years 2004 – present regarding FDA actions around communications perceived by the agency to be promoting an investigational … Continue reading →

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Weekly Roundup – 8-16-13

Posted on August 16, 2013 by Mark Senak

Oh sweet summer!  The tomatoes hang heavy on the vines, hopefully out of reach of greedy little critters.  The peaches and plums are deliciously ripe.  It is almost time to put in a second batch of basil to keep growing … Continue reading →

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OPDP Letters for Promotion of Investigational Compounds, Part 1

Posted on August 14, 2013 by Mark Senak

As many know, I have put together a data base for my use that tracks the letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) since 2004 – tracking company, date, indication, product name, type of communications vehicle and … Continue reading →

Posted in Warning Letters | 4 Comments

Weekly Roundup 8-9-13

Posted on August 9, 2013 by Mark Senak

The Congress is gone, the humidity is back.  All things considered, that is the way we prefer it.  It is that time of year where the grass appears to have had it and we find ourselves dreaming of and longing … Continue reading →

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Practicing Medicine and Practicing Social Media

Posted on August 7, 2013 by Mark Senak

While attending the 2nd ExL Digital Pharma Conference in Berlin in 2010, I listened to a dynamic presentation by a young physician from Hungary who talked about the ways that social media could – and would – make an impact … Continue reading →

Posted in Social Media | 3 Comments