FDA outlines global food, drug, device safety strategy

Agency seeks to increase cooperation with international regulatory agencies

SILVER SPRING, Md. — Globalization has led to a rapid increase in the drugs and foods arriving on U.S. shores from abroad, a trend that has prompted U.S. regulators to transform their approach.

The Food and Drug Administration released a report Monday detailing its strategies for what it called transforming from a domestic to a global public health agency.

"As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected ways to build a public health safety net for consumers around the world," FDA commissioner Margaret Hamburg said.

The report outlines several strategies that include partnerships with other agencies around the world, development and harmonization of scientific regulatory standards, increasing awareness about the importance of regulatory systems and sharing data and information globally to aid rapid identification and response to public health emergencies.

According to the agency, imports of pharmaceutical products have increased nearly 13%, while device imports and imports of food products have each increased by 10%.


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Comments

- 3:28 AM
rbalani@fdasmart.com says

Just back from India on a a US OTC drug sourcing mission. US FDA should be concerned, but the problem can be managed if we think along the lines of what Pres. Reagan has been famous for "Trust but verify" with the Russians during the cold war. WE NEED THE SAME MANTRA with India and China. Trusting at face value or based on quality agreements or written contracts is "suicide" with India and China. Americans should be very alarmed! Ram Balani CEO-Founder FDASmart Inc. Email: rbalani@fdasmart.com www.fdasmart.com

- 6:36 PM
Matthew Hoover says

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