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    I had the incredible privilege of addressing the FDA staff today at my first all-hands. I discussed three areas of priority focus – unleashing the power of data, empowering patients and consumers, as well as supporting innovation and competition.

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    31. sij

    We will all learn as we go with this. Hats off to Hahn, Abernethy, Woodcock, Shuren, Marks et al for continuing to work on this.

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  3. Recognize 2020 with us & join our public meeting on Feb 24 to discuss opportunities and challenges in product development in the era of individualized therapies. We need your thoughts on how to optimize natural history and registry studies.

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  4. Addressing rare diseases is a priority. Our Office of Orphan Products Development has an incredible technology modernization effort underway to streamline orphan drug designation requests.

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  5. The workshop will discuss evaluation needs, gaps, and approaches for medical XR, with the goal of advancing the evaluation of medical XR devices and applications, accelerating development while ensuring safety and efficacy.

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  6. Medical extended reality is growing and we want to hear from you on best evaluation practices in virtual reality and augmented reality in medicine. Join us at our public workshop on March 5 and share your expertise

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  7. As part of the at , I had the chance to talk to about all the great ways we are looking to improve our data strategy at FDA.

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  8. : We announced a public meeting on Modernizing FDA’s Data Strategy today!

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  9. Thanks to for hosting today’s chat with me at . We had a great conversation on how FDA is working to modernize our data strategy.

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  10. In just a few minutes, I'll be participating in a Q&A at for the . I'm excited to be here, and I hope to see you there! Follow live coverage of the event at .

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  11. The research approach used to study the safety &effectiveness of the vaccine was precedent-setting during a public health emergency & may help create a model for future studies under similar circumstances.

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  12. Late yesterday, we announced the first FDA-approved vaccine for prevention of Ebola virus - a significant public health achievement, that will help protect against Ebola as well as advance U.S. government preparedness efforts.

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  13. Today, FDA issued a draft guidance to provide some clarity regarding evidence needed to demonstrate effectiveness for drugs and biologics.

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  14. Have you seen our new CURE ID app? It’s where health care professionals can report on novel uses of existing medicines for patients with difficult-to-treat infectious diseases, making it easier to spot promising new uses for existing drugs.

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  15. Join the workshop to discuss benefits and risks of using artificial intelligence in radiological imaging, including emerging applications such as AI-guided image acquisition and diagnostic radiology workflow automation.

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  16. We want to hear from you on the use of artificial intelligence (AI) in radiological imaging. Join the FDA at a public workshop on the evolving role of AI in radiological imaging Feb. 25-26, 2020 and comment on the open docket on .

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  17. FDA is concerned that people may mistakenly believe that trying CBD “can’t hurt.” Use of any CBD product should always be discussed with a health care provider. To read more about the potential risks see FDA’s Consumer Update:

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  18. This week, FDA provided an update for consumers about CBD. Importantly, consumers should know there is limited available information about CBD, including about its effects on the body.

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  19. There are number of questions regarding CBD’s safety and there are real risks that need to be considered. There is significant interest in CBD and we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products.

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  20. Often, people wrongly think that the myriad of CBD products on the market have been evaluated by FDA and determined to be safe, or that trying CBD can’t hurt. Aside from one prescription drug, CBD products have not been approved by FDA.

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