Monthly Archives: April 2013

Weekly Roundup – 4-26-13

Posted on April 26, 2013 by Mark Senak

The spring clothes are headed to the closet, while the winter clothes are headed to their space for their seasonal slumber until next Fall.  The days are sunny. The winter mess in the yard has been cleared away (mostly) and … Continue reading →

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Warning and NOV Summary – 1st Quarter 2013

Posted on April 25, 2013 by Mark Senak

Each quarter I regularly try to provide a little insight into OPDP’s current thinking as expressed through the issuance of Warning and NOV letters.  What we saw last year is that the number of such letters after rising a bit … Continue reading →

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Weekly Roundup – 4-19-13

Posted on April 19, 2013 by Mark Senak

It has been a really busy week with travel and work that last Friday I didn’t even get to the Weekly Roundup.  The schedule has been so busy, leaving no spare time for either posting here on the blog or … Continue reading →

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Comparing Types of Violations Between Digital and Non-Digital

Posted on April 11, 2013 by Mark Senak

In the wake of publishing “FDA Communications Oversight in a Digital Era” in last week’s blog post, I have been asked some interesting questions.  One of them sought to know whether there was a difference between the types of violations … Continue reading →

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Weekly Roundup – 4-5-13

Posted on April 5, 2013 by Mark Senak

The daffodils are up and being rounded up in bunches and slipped into vases around the house, spreading good cheer, but overall Spring is still seemingly quite shy though indications are that is about to change.  It is perhaps a … Continue reading →

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