Category Archives: Uncategorized

AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019

The system of FDA Advisory Committees is in place so that when FDA needs advice – either on policy development, reviewing an issue with an already approved medicine, or regarding new drug approvals – the agency has a lot of … Continue reading

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Update on FDA Approvals for 2019

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

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 1-3-14

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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