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Regulatory Focus™ > News Articles > Quality & Compliance: Preparing for Health Authority Interactions and Advisory Committees

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

Posted 01 February 2009

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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