Posted by Michael Wonder on 05 Sep 2018
Statement from FDA Commissioner on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities
5 September 2018 - Over the past 25 years, globalisation 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.
We’ve established a framework to help assure that drug products all meet the same high-quality standards, regardless of where they’re manufactured; and whether they’re brand name or generic products, or prescription or over-the-counter drugs. Today, we’re announcing several steps that improve on that effort.
