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How FDA Advisory Committee Members Prepare and What Influences Them

Since 1992 many changes have occurred in the regulations, guidelines, and processes governing the FDA, the biomedical industry, other stakeholders, and their interactions. Of particular importance, the FDA Amendments Act of 2007 made public advisory committee meetings mandatory for new molecular entities and devices requiring clinical trials, unless the necessity of convening such a meeting has been waived by the FDA commissioner.

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RAPS Texas Chapter Meeting

July 17, 2014 The Steps to a Successful Advisory Committee or Device Panel Meeting  

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RAPS Florida Chapter Meeting

May 6, 2014 The Steps to a Successful Advisory Committee or Device Panel MeetingĀ   

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