| Note: Some items noted herein were prepared prior to the change in Administration and may reference Stephen Hahn, M.D., Commissioner of Food and Drugs, Food and Drug Administration (FDA). Janet Woodcock, M.D., was named Acting Commissioner of Food and Drugs, FDA on January 20, 2021.  Accelerating the adoption of advanced manufacturing technologies to strengthen our public health infrastructure 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 FDA 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." FDA is creating a new collaboration with the National Institute of Standards and Technology (NIST) through a memorandum of understanding (MOU). This MOU is intended to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products and medical devices through adoption of 21st century manufacturing technologies. Related links: Emerging SARS-CoV-2 variants FDA continues to closely monitor the various identified variants of the virus that causes COVID-19 circulating globally, as well as monitoring for emerging variants. We will continue to factor in newly emerging information in light of our role in regulating diagnostics, therapeutics and vaccines to fight COVID-19. We are assessing the impact of the new strains on authorized products and are working with medical product sponsors to provide information on evaluating any potential impact that these or other variants may have on effectiveness of their products. At this time, available information suggests that currently authorized vaccines remain effective in protecting the American public against current strains of COVID-19. FDA has already given thought to developing a potential pathway, should changes need to be made to authorized COVID-19 vaccines or other products based on information on emerging variants. We are committed to having a public and transparent process around our path forward. The agency has experience with other situations where such changes are needed, for example, as is the case with influenza virus vaccines. FDA is planning for all scenarios to ensure that we address any impacts to products as quickly as possible. (January 25, 2021 statement from Dr. Janet Woodcock) Upcoming events Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity  |
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