Category Archives: Advisory Committee Prepapartion

Sorting it Out – FDA AdComm Review for 2019

Has FDA been holding enough AdComms? There have been a large number of drugs approved in the past year, but there has not been a corresponding increase in the number of advisory committees staged by FDA. Late in 2019, I … Continue reading

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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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Advisory Committee Activity for 2017

Having worked with a lot of companies to prepare for an FDA Advisory Committee (AdComm) , I track the activities of the committees in a database marking outcomes, votes and other characteristics. As part of a look-back series as we … Continue reading

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AdComm Activity for 2016 – How Did They Vote?

The number of new drugs approved by FDA last year fell – by many indicators. There were fewer new molecular entities approved and there were fewer press releases about approvals during the year compared to 2015. And consequently, there were … Continue reading

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Regulation Cutting Impact on FDA and AdComms

During the campaign, candidate Donald Trump made several statements referring to the fact that he would be cutting regulation in this country by 70-80 percent. Since the election, that sentiment has been repeatedly affirmed. Now in office, this week he … Continue reading

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