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  Vol. 302 No. 11, September 16, 2009 TABLE OF CONTENTS
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FDA Boosts Enforcement

Bridget M. Kuehn

JAMA. 2009;302(11):1162.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The US Food and Drug Administration (FDA) will act more swiftly and aggressively to mitigate public health threats under a tough new enforcement agenda outlined in August by Margaret A. Hamburg, MD, the agency's new commissioner.

Hamburg explained that despite efforts of dedicated career staff at the FDA, enforcement actions have been bogged down by arduous processes at the agency (http://www.fda.gov/NewsEvents/Speeches/ucm175983.htm). The result has been unacceptable delays in actions to protect the public health, she said.


Figure 90007FA
FDA Commissioner Margaret A. Hamburg, MD, has laid out a plan to more rapidly and aggressively react to public health concerns. (Photo credit: FDA)

Many of the steps the agency will be taking to remedy these problems focus on increasing the speed of enforcement actions, Hamburg said. For example, the agency will establish deadlines, usually no more than 15 days, for a company to respond to inspection findings before . . . [Full Text of this Article]



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