Category Archives: Advisory Committee Prepapartion

FDA Advisory Committee Action for 2012

As 2011 ended, there was a great deal of looking back at events of the year.  As it affected new medical products, FierceBiotech reported on Friday that drug approvals during the year increased to 30 last year. Now as we … Continue reading

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FDA Making Transparency Increasingly Clear

This week a number of people took note when the FDA announced the issuance of a report that outlined eight new proposals to increase transparency by allowing greater access to the agency’s compliance and enforcement data.  The eight proposals are … Continue reading

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AdComm Vacancies and Conflict of Interest Standards

Last week at the Reuter’s Health Summit held in New York, Janet Woodcock, the head of the Center for Drug Evaluation and Research was quoted as saying that she expected drug approvals to increase this year, but that the financial … Continue reading

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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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