Category Archives: Uncategorized

Update on FDA Approvals for 2019

Posted on October 3, 2019 by Mark Senak

Last year new molecular entities (NMEs) were approved by FDA at a record clip, surpassing the prior record of 45 that was set in 2015. As we begin the final quarter of hte year, this is a good time to … Continue reading →

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What They Said – A Review of FDA Press Statements for 2018

Posted on January 10, 2019 by Mark Senak

Periodically it is a good idea to take the pulse of what FDA is saying. This is not by looking at each press release individually, though of course that is important, but rather to look at the aggregate of what … Continue reading →

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Happy New Year – and FDA Statement on Government Shutdown

Posted on January 2, 2019 by Mark Senak

Happy New Year. On a personal note, I have been on a hiatus or shutdown myself to take time while undertaking a move. With that behind me, I am back at it and will be posting again with intermittent content … Continue reading →

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Weekly Roundup 1-3-14

Posted on January 3, 2014 by Mark Senak

What?  A Weekly Roundup after such a short quiet week?   And a week when there was a snow storm to boot?  Even these sheepdogs can’t find the sheep to round up!  Well it may have seemed like a quiet, … Continue reading →

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A Look Back at 2013 and FDA

Posted on January 2, 2014 by Mark Senak

Happy New Year!  It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come. … Continue reading →

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