miércoles, 5 de septiembre de 2018

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities









Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and make sure consumers continued to receive safe and effective drug products.

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