Monthly Archives: February 2015

Weekly Roundup 2.27.15

Posted on February 27, 2015 by Mark Senak

Another round of snow this week, perhaps the last gasp of winter? I can’t say there is any hint of Spring in the air in these parts, but sure hope there is where you are. In any event, I am … Continue reading →

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Legislative Proposals in the 114th Congress

Posted on February 25, 2015 by Mark Senak

Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed.  The new Congress has just two months old and while the last Congress was … Continue reading →

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Weekly Roundup 2.20.15

Posted on February 20, 2015 by Mark Senak

Friiiiiiggggggiiiiiiiddddd.  I realize anyone who doesn’t live in the Northeast can’t really complain, but winter finally woke up in the capital of our nation. Last week I took a picture of green daffodil sprouts coming up from the grounds of … Continue reading →

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The Language of Risk – FDA’s Evolution of Thought

Posted on February 19, 2015 by Mark Senak

How does the average patient assess the risk of a medical product when deciding whether or not to seek it out? This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk … Continue reading →

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Weekly Roundup 2.13.15

Posted on February 13, 2015 by Mark Senak

Happy Friday the 13th and the day before Valentine’s Day. It is cold.  There is fierce wind. Boston is due more snow. As if there aren’t enough reasons to dislike February…. For me the week flew by and I hope … Continue reading →

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