FDA Long-Term Globalization Strategy Under Development

Article preview from "The Gray Sheet" - February 14, 2011

Coping with an increasingly global device and drug industry will require a paradigm shift that relies less on FDA's own staff and more on data and resource sharing with other countries, the agency says.

FDA Long-Term Globalization Strategy Under Development

Article preview from "The Gray Sheet" - February 14, 2011

Coping with an increasingly global device and drug industry will require a paradigm shift that relies less on FDA's own staff and more on data and resource sharing with other countries, the agency says.

"FDA's traditional model of manufacturing site inspections and border examinations is simply not adequate in today's transformed world," said John Taylor, who was recently named acting principal deputy commissioner of FDA following the departure of Joshua Sharfstein in January.

"The truth of the matter is that the increase in imports is just far outstripping the resources to address this issue," he emphasized at a Feb. 10 meeting in Washington, D.C.

FDA estimates that U.S. imports of regulated products including medical devices, drugs, food and cosmetics have increased three-fold over the last decade.


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