Category Archives: Advisory Committee Prepapartion

Advisory Committees – The Missing Links and The Vacancies

Every so often, I check in to see how the agency is faring when it comes to Advisory Committee transparency.  The last time I did a chart like this several months ago, CDER and CBER figured in for having about … Continue reading

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Practical Need-to-Know Tips About Changes to AdComm Preparations

The FDA has been settling into their new digs in Montgomery Maryland called White Oak, and the move of such a large agency into a new facility has been a process, not an event, as one might imagine. The old … Continue reading

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FDA AdComm Calendar for 2011 – Where is the Action?

At nearly the end of 2010, the FDA published the tentative calendar for advisory committee meetings for 2011.  Naturally, the agency cannot precisely detail the calendar at this stage, but it does provide a bit of a signal regardomg the … Continue reading

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Guidance on Comments – Advisory Committee Prep on Open Public Comment Period

As noted in the Weekly Roundup on Friday, last week the FDA published a Final Guidance on the Open Public Comment period at FDA Advisory Committee meetings.  On a side note, it is perhaps worth noting that this updated the … Continue reading

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Communications and Marketing Implications of a Change in FDA Policy for Medical Device AdComms

In June of 2008, January of 2009 and again in June 2009 the General Accounting Office issued reports on the FDA and its oversight of medical devices.  The June 2009 report echoed findings from the earlier January report, put forth a recommendation … Continue reading

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