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Archive for December, 2007

FDA Needs Help

The rise in Qui Tam cases that we and other qui tam law firms have experienced is no doubt a result of the lax enforcement that has occurred over the years-as fraud has been allowed to increase.This month, consistent with the notion that the FDA has been under-resourced from a regulatory enforcement standpoint, the FDA’s Subcommittee on Science and Technology issued a report which concluded, in part, that:

The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.

The FDA lacks the information science compatibility and information infrastructure to fulfill its regulatory mandate

The FDA cannot provide the information infrastructure support to regulate products based on new science.

In the scathing 300-page report , the distinguished subcommittee panel of experts concludes that the state of FDA’s scientific and regulatory programs could not be separated from the lack of resources. It urged appropriate funding to support the FDA’s scientific workforce and information technology infrastructure.

Its report has been posted on the FDA website and is available here.

To read more about the False Claims Act application to FDA violations, click here.

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Posted By Marcella Auerbach Responces 0
Category Legal Posted December 4th, 2007

 

  

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