La US FDA souhaite accélérer l'adoption de technologies de fabrication avancées

By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Colin Rom, Senior Advisor to the Commissioner

Remember in-person meetings? A year ago, would you have thought our world, our homes and offices would be upended and changed so rapidly? Seemingly overnight businesses were adapting to a new reality.  We at U.S. Food and Drug Administration adapted as well – we had to. Our mission is so critical, we couldn’t fall behind because too much was, and still is, at risk. At the start of this 21st year of the 21st Century, businesses, manufacturers, the FDA, and patients, are all adjusting to the changing times and adopting new trends. For the day-to-day work of the FDA those changes are focused on advanced manufacturing technologies, digital industry and “Industry 4.0.”

Advanced manufacturing technologies are being adopted by both small businesses and large corporations in ways that are changing the industry and regulatory landscape. The FDA has dedicated significant effort over the past several years to establishing both research and regulatory programs for advanced manufacturing, computational modeling, and other emerging technologies. These efforts have led to updated regulatory processes, guidance documents and dozens of peer-reviewed research publications to identify characteristics of advanced manufacturing processes that can provide regulatory evidence of quality, safety and efficacy. The FDA also encourages use of advanced manufacturing through involvement in new standards development and industry outreach...

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