Tuesday, July 5, 2011

FDA Report: Pathway to Global Product Safety and Quality

In June, 2011, the U.S. Food and Drug Administration released their new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain.

Details of the plan are contained in a report called the "Pathway to Global Product Safety and Quality."

The FDA report calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers.

The report identifies four key elements needed to make the change:

1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.

2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

3. The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.

4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

source: FDA

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