Quality & Compliance: Preparing for Health Authority Interactions and Advisory Committees

Posted 01 February 2009 | By

Many mainstream and trade journalists have recently noted that the US Food and Drug Administration (FDA) has become more cautious and sometimes harsh in its reviews of drug/biologic/medical device safety and efficacy data. Because of this, professionalism in the presentation of data and responses to challenging division staff and advisory committee questions has become critically important.


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