Janeen A. Skutnik

Janeen A. Skutnik is director of Quality & Regulatory PolicyGlobal Regulatory CMC at Pfizer.

The Food and Drug Administration Safety and Innovation Act (FDASIA) is a remarkably broad law with far-reaching implications for the pharmaceutical industry. Several provisions of the law focus on ensuring safety and quality in the increasingly global pharmaceutical supply chain. Learn more?

This position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.