Resources for Food and Drug Administration (FDA)

Exciting Developments At The FDA - Annual Meeting Of The American Urological Association

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Dr. Andrew von Eschenbach discussed developments at the FDA. He addressed the FDA mission to protect and promote public health. The FDA has been in existence since 1906. The FDA regulates 20% of everything we consume to include most food, drugs, medical devices, animal feed and drugs, cosmetics and radiation devices. The budget for this is modest at 2.27 billion dollars. The FDA has 10,000 employees. The resources are thus not commensurate with the challenges.

Globalization and advances in science and technology are present challenges at the FDA. There are 295 active US points of entry. This includes food, dietary supplement, drugs, cosmetics, devices and animal food. Drugs are primarily coming from India and China. Their infrastructure is less developed than in the US and the recent news of contaminated heparin from China is an example. FDA notification occurred in January 2008, and they identified a common source in China. 81 deaths occurred and analysis using sophisticated techniques identified contamination with over-sulfated chondroitin sulfate. This was all addressed and corrected in 2.5 months. This has altered the FDA's oversight, to now cover the complete life-cycle of products from production to consumption. Prevention, intervention and response are the new approach. They are launching "FDA beyond our borders" with 5 oversea FDA offices.

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