Monthly Archives: April 2014

Mind and Heart

Posted on April 29, 2014 by Mark Senak

The Washington Post recently carried an article regarding an investigative compound being studied for the treatment of Duchenne muscular dystrophy which affects young boys – a condition for which there is no current treatment.  The course of the condition means … Continue reading →

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Weekly Roundup – 4.25.14

Posted on April 25, 2014 by Mark Senak

It has been one of those weeks where each day I felt it was supposed to be the day after. Monday I thought was Tuesday, Tuesday, Wednesday and so on. Here at last, I think, is Friday – the real … Continue reading →

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Upcoming AdComms by Subject Matter

Posted on April 22, 2014 by Mark Senak

In prior years, near the end of a calendar year, FDA would put up a schedule of Tentative Advisory Committee Meetings with tentative meeting dates scheduled for each Advisory Committee.  This year, however, the calendar went up, but very few … Continue reading →

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Warning and NOV Letter Summary – 1st Quarter 2014

Posted on April 21, 2014 by Mark Senak

Each quarter, I provide an overview of the most recent Warning and NOV letters from OPDP to gain insight into any lessons learned and to look at overall trends.  But this quarter, it is really slim pickings.  More than slim … Continue reading →

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Weekly Roundup – 4.18.14

Posted on April 18, 2014 by Mark Senak

There were audible gasps all over the Internet from people experiencing yet more snow this week – the week of Easter break for many.  Freeze warnings here threatened my young herbs planted only a few days before over a warm … Continue reading →

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