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Published on 1 October 2007

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Bush approves law boosting FDA’s powers


US President George W. Bush has signed a law giving the FDA wide-ranging new powers.

The legislation will let the FDA collect fees from drug and medical device manufacturers over the next five years to offset costs to the FDA of reviewing products.

The law also empowers the regulator to demand that drug firms conduct further studies on medications, and issue new warnings on labels if problems occur.

Additionally, the FDA will be able to fine companies if they do not comply with these measures.

Pharmaceutical firms will even be obliged to publicly release results of all clinical trials, although the level of disclosure is still being discussed.

The law calls for drug companies to pay $393m and medical device makers $48m in various fees next year.

FDA commissioner Dr Andrew von Eschenbach said: “The Act continues essential and successful programmes that will enhance FDA’s ability to more efficiently and effectively regulate drugs, biological products and medical devices.

“It will provide enormous benefit to the public health by allowing FDA to continue to deliver safe and effective medical products to Americans every day.”

Copyright © PA Business 2007


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