Monthly Archives: May 2015

Weekly Roundup 5.29.15

Posted on May 29, 2015 by Mark Senak

In spite of the fact that summer does not officially begin until the Summer Solstice which will occur on Sunday, June 21, if you are like me and many others the unofficial beginning of summer happens on Memorial Day. And … Continue reading →

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Advisory Committee Track Records

Posted on May 28, 2015 by Mark Senak

Needless to say, every time a product goes before an FDA Advisory Committee (AdComm), there are circumstances that make the deliberations that occur during that meeting a unique experience. A specific investigative compound being studied for a specific indication with … Continue reading →

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Weekly Roundup 5.15.15

Posted on May 17, 2015 by Mark Senak

Today is one of those days where if you took the date and read it backwards – 5.15.15, it would still be the same date and it has pretty much been that way all week. 5.14.15, 5.13.15 and so on. … Continue reading →

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The Guidance that Dare Not Speak Its Name

Posted on May 13, 2015 by Mark Senak

In December 2014, Commissioner Hamburg announced a proposed change in the FDA’s long-standing policy regarding blood donations from gay men – See “FDA Commissioner Margaret A. Hamburg’s statement on FDA’s Blood Donor Deferral Policy for Men Who Have Sex With … Continue reading →

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Weekly Roundup 5.8.15

Posted on May 8, 2015 by Mark Senak

It is one of my three favorite times of year – the days are so much longer – the evenings cool and pleasant for sleeping near open windows – the mornings crisp and the afternoons languidly warm. Flowers abound. There … Continue reading →

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