The development of harmonized international standards for drugs and biologics has been an important undertaking for the last decade. These initiatives will continue to play a central role in ensuring drug product quality on a global basis. FDA also is working with other regulatory authorities to explore new models for accepting inspection findings from local agencies that can, in some cases, reduce the need for US inspectors to travel overseas. Although some policymakers will object to reduced direct oversight of medical products manufactured overseas for US consumers, FDA's limited resources will necessitate the increased reliance on capable foreign regulators to support US oversight of global pharmaceutical production.

Jill Wechsler, Washington editor,
Pharmaceutical Technology

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