Category Archives: Advisory Committee Prepapartion

Advisory Committee Track Records

Needless to say, every time a product goes before an FDA Advisory Committee (AdComm), there are circumstances that make the deliberations that occur during that meeting a unique experience. A specific investigative compound being studied for a specific indication with … Continue reading

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AdComms for Last Quarter of 2014

It is hard to believe it, but we have entered the final quarter of 2014.  I thought it a good time to revisit the upcoming AdComm schedule for those AdComm meetings that affect drugs or devices. Prior postings that provided … Continue reading

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Upcoming AdComms By Subject Matter

In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so … Continue reading

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Upcoming AdComms by Subject Matter

In prior years, near the end of a calendar year, FDA would put up a schedule of Tentative Advisory Committee Meetings with tentative meeting dates scheduled for each Advisory Committee.  This year, however, the calendar went up, but very few … Continue reading

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Building a Case, FDA AdComm Prep – Part 3 (final)

In Part 1, we covered the need for good communications planning, in Part 2, a little bit about how to go about it and in Part 3, some thoughts about the day of your meeting. You have developed your narrative … Continue reading

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