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U.S. FDA Enforcement Priorities Include Globalization Threats

This article was originally published in PharmAsia News

Executive Summary

U.S. FDA will overhaul its enforcement approach to reflect the impact of globalization by partnering more with foreign counterparts, streamlining inspections, recalls and emergency responses and using stiff criminal sanctions to deter noncompliance, agency officials say.

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Enforcement In Brief

GMP violations lead to prison time; Syntec supplements seized; FDA warns NanoLiposomal Nutritionals; and more Enforcement In Brief.

Collaboration On Foreign Inspections Helps FDA Improve Resource Allocations

FDA better allocated resources for foreign inspections based on information European and Australian authorities shared in a two-year pilot program, including conducting good manufacturing practices inspections that met the needs of multiple agencies.

Threat Of Adulteration For Profit Grows With Globalization Of Supply Chain

Deliberate adulteration of dietary supplements for economic gain is a growing threat that FDA and the food and drug industries must work together to neutralize, according to the agency's food safety chief and a trade group executive





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