Monthly Archives: April 2006

Weekly Roundup

Posted on April 21, 2006 by Mark Senak

A New and Regular Feature – I’ve decided to use Friday’s as a time to round up the small news, stuff you might not have been able to notice, or if you did, to think about much.  New Appointment at … Continue reading →

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Warning Letter Summary for First Quarter 2006

Posted on April 20, 2006 by Mark Senak

After the end of each quarter, I would like to make it a point to review the FDA Warning Letters issued from DDMAC and describe the nature of the letters and the violations.  The point will be (i) to highlight … Continue reading →

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100 Years of Fortitude

Posted on April 19, 2006 by Mark Senak

The FDA is celebrating its 100th birthday.  Like the FDA’s Critical Path Initiative (CPI) (see prior posting on this topic), this is an opportunity to get some messaging out there to support the agency.  However like the CPI, it appears … Continue reading →

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The Bio Conference and the FDA Survey

Posted on April 18, 2006 by Mark Senak

The BIO conference was held last week in the wonderful city of Chicago.  A lot of people have been writing about it.  So I decided to join in.  The blog On Pharma has some very nice daily updates.  Former President … Continue reading →

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Avoiding a Crisis in Communications during a Medical Product Crisis

Posted on April 17, 2006 by Mark Senak

Looking back over the week, one of the events of note was the issuance of an alert by FDA that warned contact lens wearers of the possibility of fusarium keratitis, a fungal infection that can occur in the eye and … Continue reading →

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