Posts Tagged ‘drug and device complexity’

Increasing Drug & Device Complexity: Impact on the U.S. Regulatory Review Process

December 8th, 2010
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Last week, PwC issued a report entitled “Improving America’s Health V—A survey of the working relations between the life sciences industry and FDA.” In a release announcing the report, PwC explained,  “Growing public demand for increased medical device and drug safety, as well as the need to develop medical products faster, is complicating the current regulatory approval process and relationship between the life sciences industry and its chief regulator, the U.S. Food and Drug Administration.”
I certainly agree that the FDA as a resource is constrained. This is a somewhat predictable predicament, however, in that products being considered for marketing approval as well as those currently regulated by the FDA are more complex today than ever before. As complexity rises, the agency clearly needs more resources and augmentation in specific skill areas, such as informatics and genomics.
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