Dr. Stephen M. HahnOvjeren akaunt

@SteveFDA

24th Commissioner of Food and Drugs -

Silver Spring, MD
Vrijeme pridruživanja: prosinac 2014.

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  1. Prikvačeni tweet

    At the FDA, we are working hard to prepare, mitigate & respond to , in close coordination with our federal partners. This collaboration, as noted, reflects our shared commitment to public health.

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  2. FDA is dedicated to working with other 2019-nCoV diagnostic developers to help accelerate development programs and requests for EUAs, in fact several have already requested and received the EUA template for this outbreak.

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  3. I want to thank our experts who prioritized this review & worked closely with the scientists who rapidly developed this diagnostic tool, as well as who are responsible for laboratory oversight & helped provide timely guidance.

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  4. This EUA highlights the power of collaborative efforts to advance critical medical products during this current outbreak & future public health emergencies.

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  5. Today’s EUA is the result of the close collaboration between FDA and to prioritize and rapidly respond to the need to develop critical medical products as part of the US Govt response to the outbreak.

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  6. As a precaution, FDA has provided information to blood establishments may wish to consider for providing donor education, encouraging self-deferral and managing post-donation information in response to the 2019-nCoV outbreak.

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  7. Routine donor screening that already takes place should prevent individuals with respiratory infections including 2019-nCoV from donating blood. Donors must be in good health and have a normal temperature when they donate.

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  8. The safety of the nation’s blood supply is a top FDA priority. We’ve received questions about the potential impact of the novel coronavirus (2019-nCoV) on blood safety. Respiratory viruses are generally not known to be transmitted via blood transfusion.

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  9. As this dynamic situation unfolds, I’m depending on them for their expertise and vigilance to ensure the American public’s safety. I’m honored to serve with these professionals every day.

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  10. I met with FDA’s Commissioned Corps leaders yesterday to discuss their important work in protecting the public health. They are absolutely critical in our response efforts in public health emergencies like novel .

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  11. The workshop explored key considerations for using real world evidence to transition EUA authorized devices to full marketing status. We’re continuing our collaborative work across the public and private sector to prepare, mitigate and respond to outbreaks.

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  12. Today, FDA cohosted a public workshop with on Advancing Emergency Use Diagnostic Products Toward Full Marketing Status. Planned well before the outbreak, it’s especially timely now.

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  13. Competition is key to bringing down costs and providing American patients with more choices for the critical therapies they need. The FDA and the FTC will work together to deter anti-competitive business practices in this space and support a robust market for biosimilars.

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  14. I’m pleased to announce today an effort that enhances FDA’s partnership with the – FTC Chairman and I have signed a joint statement to support a competitive marketplace for biological products.

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  15. FDA is also working diligently to help facilitate the expeditious development & availability of critical medical products to diagnose, treat & prevent novel .

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  16. FDA will continue to work closely with , U.S. & international partners as part of a coordinated response as we all continue to closely monitor this outbreak.

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  17. .’s declaration of a Public Health Emergency on novel is part of the Administration’s work to monitor, respond to, and mitigate the spread of the . At this time, the risk to the American public remains low.

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  18. Patients, parents/guardians must also be counseled on – among other things – the need to have injectable epinephrine available for immediate use at all times, need for continued dietary peanut avoidance & how to recognize anaphylaxis signs/symptoms that may occur w/ product use.

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  19. Even with strict avoidance, inadvertent exposures to peanuts can & do occur. FDA approved a new drug, that when used in conjunction with peanut avoidance can help reduce the risk of these allergic reactions in children with peanut allergy.

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  20. Peanut allergy affects approximately 1 million children in the U.S., and only 1 out of 5 of them will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions.

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  21. We have made it clear, we will not tolerate violations of federal tobacco regulations designed to protect the American public – especially underage tobacco sales to youth. In this case, the FDA was prompted to take action because Smart Toothpicks ignored the laws.

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