Author Archives: Mark Senak

Sorting it Out – FDA AdComm Review for 2018

In 2017, the Advisory Committees voted to recommend approval 71.4 percent of the time; in 2018 it was 66.6 percent. Continue reading

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

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

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 11.9.18

So much to talk about, so little time. The election (thankfully) is over. The days are shorter, darker, wetter and altogether more lean. Thanksgiving is but a few short weeks away and Christmas decorations are already sneaking their way into … Continue reading

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Weekly Roundup 11.2.18

We are shifting gears as we head into the year’s end, with two months to wrap everything up and we kick it off by ending Daylight Saving 2018 this weekend – so remember to set your clocks back (Fall Back) … Continue reading

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