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June 2009

FDA's Evolving Civil Money Penalty Authority: Simple Violations Can Lead to Major Costs

The U.S. Food and Drug Administration (FDA) has several enforcement tools at its disposal, including warning letters, injunctions, seizures, and criminal prosecutions. While most industry professionals are familiar with these enforcement tools, FDA's civil money penalty (CMP) provisions may be less familiar to some. In the past five years, CMPs have emerged as an important enforcement tool as Congress has increasingly expanded FDA's authority to impose such penalties. With the expansion of FDA's CMP authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the number of CMP cases will likely increase in the coming months and years.

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Current Political Climate Favors Passage of Drug and Device Accountability Act of 2009

Although essentially the same as its 2008 predecessor, the recently announced Drug and Device Accountability Act of 2009 is much more likely to become law in today's more favorable, "accountability-conscious" political climate. If and when this happens, the bill will subject product applications that contain false or misleading information to stiff fines (up to $5,000,000), and these fines will be assessed both to companies and their senior officers, who, in addition, will face jail sentences of up to 20 years.

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Did You Know?

Navigating the FDA's New Requirements for eCTD Submissions
June 9-10, 2009, Boston, MA

Regulatory Affairs Professional Society - Advanced Workshop for Preparing Compliant eCTDs
August 6-7, 2009, Rockville, MD

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Did you know that the FDA is pursuing a future where all regulated product information will be electronic? The FDA is currently implementing numerous systems which promise to usher in a new era of electronic interactions between the agency and its constituents (i.e. industry and consumers).

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