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12:00 AM
May 29, 2006
 |  BioCentury  |  Regulation

FDA's plethora of meetings

FDA's Center for Drug Evaluation and Research holds eight or nine meetings with drug sponsors on a typical day, far more than other drug regulators, and the information communicated at these encounters can have substantial, long-term effects on drug development programs. However, differing recollections of the actual advice given by FDA staff can lead companies to inadvertently choose a path that will result in the agency's rejection of clinical trial results.

The agency has launched two new initiatives intended to ensure that meetings run smoothly and that both parties have good written records summarizing the discussions and outcomes. Although efforts to improve the meeting process are not new, the agency is motivated by data showing that sponsor meetings with FDA early in the development process is positively correlated with faster reviews and reduced expenditures of agency resources (see BioCentury, Feb. 13).

FDA-sponsor meetings are conducted on deadlines that are spelled out in the Prescription Drug User Fee Act, which is up for reauthorization in 2007. In its negotiations with industry over the next agreement, FDA already has indicated it will ask for an increase in user fees to defray costs associated with meetings. In exchange, it is offering a more reliable, consistent process.

The meeting initiatives are part of a broader effort inside the agency to make sure that the regulatory process...

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