Monthly Archives: May 2009

Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 1

Posted on May 18, 2009 by Mark Senak

It is always a good idea to review the content of Warning and untitled letters to learn from the lessons being taught be DDMAC with respect to communications that promote the marketing of pharmaceutical, biotech and device products.  However, I … Continue reading →

Posted in Warning Letters | 1 Comment

Weekly Roundup – 5/15/09

Posted on May 15, 2009 by Mark Senak

Days and days of torrential and sporadic rains have taken their toll.  With all the wet, the weeds in the garden  prosper while my unplanted daisies languish in their little plastic cups waiting and yearning for the wide expanse of … Continue reading →

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Crisis Communications in the Digital Era

Posted on May 14, 2009 by Mark Senak

On May 5 I participated in a Webcast that laid out considerations for businesses in pandemic communications planning.  The attendance and coverage were great.  But it occurred to me afterword that many of the things I was outlining were steps … Continue reading →

Posted in Crisis Communications | 1 Comment

FDA Issues Warning Letter on Cheerios – Priorities Askew

Posted on May 13, 2009 by Mark Senak

This is not a joke -at least they didn't intend it to be.  You can decide.   On May 5, the FDA issued a Warning Letter to General Mills because of the promotional claims on a box of Cheerios.  Here … Continue reading →

Posted in FDA Image, FDA Policy, Warning Letters | 6 Comments

Comparative Effectiveness Comparatively Speaking

Posted on May 11, 2009 by Mark Senak

Just what is comparative effectiveness research (CER)?  It seems that as many opinions exist as there are people to express them.  This past month, there has been a good deal written about comparative effectiveness, particularly as President Obama included $.1 … Continue reading →

Posted in Comparative Effectiveness | 3 Comments