FDA Global
@FDA_Global
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Office of Global Policy and Strategy carries out FDA's global public health mission: overseeing foreign offices, trade policy, bilateral/multilateral relations.
Silver Spring, MD
Joined June 2019
FDA's latest From a Global Perspective is out. Read how Japan’s regulatory leaders are collaborating with the FDA & what they are doing to encourage global drug companies to market their new drug products in Japan. https://t.co/rpZC7quhad
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📣 New OWH publication: Check out this article, published in @BMC_series Pregnancy and Childbirth, which examines the severity of delivery-related #MaternalHealth outcomes & offers an improved metric that can help inform better care practices, policies, & support systems for
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FDA announces a public workshop on improving access to epinephrine for anaphylaxis treatment. Seeking input on barriers & solutions to reduce deaths from severe allergic reactions. Virtual event Dec 16. Register: https://t.co/eKcgiP2qTv
#Anaphylaxis #PublicHealth
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Older adults face unique challenges in cancer care. Join the #FDAOncology Conversations on Cancer discussion: “Empowered Choices: Perspectives on Cancer Care Decision-Making Among Older Adults.” 📅 Dec. 11, 2025 | 💻 Virtual event https://t.co/LJd0bwXiKQ
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Delivering the opening remarks of the 10th Advanced GMP Workshop 2025, Gregory Smith, Country Director of the @US_FDA India Office, underscored India’s vital role in strengthening global health systems. He highlighted how India’s scientific capability, manufacturing depth, and
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#FDA approves a treatment for follicular lymphoma indications. [FDA approves epcoritamab-bysp for follicular lymphoma indications | FDA].
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FDA published 76 new and revised product-specific guidances to improve access to safe, effective, & affordable medications. PSGs facilitate the timely development of high-quality generic drugs by bringing greater efficiency and transparency to the process. https://t.co/oaWQlcscdq
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🎤 SEE NOW: Principal Deputy Commissioner Sara Brenner's opening remarks from FDA’s meeting this week with @DukeMargolis. Hear the agency’s vision for advancing RWE in medical product development. https://t.co/Q4iSWY0PT7
fda.gov
Opening Remarks by Sara Brenner, U.S. Food and Drug Administration September 23, 2025
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FDA eliminates special safety requirements (REMS) for Caprelsa cancer drug after >decade of successful monitoring. Health care providers now have adequate knowledge to safely manage heart rhythm related risks without mandatory protocols. #CancerTreatment
https://t.co/23n6Yx8AQt
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🎯 Join the FDA's 10th Annual Clinical Outcome Assessment in Cancer Trials Workshop! Oct 8, 1-3:30pm ET (virtual). A decade of progress in patient-reported outcomes. Essential for researchers, clinicians & patient advocates. #CancerResearch #PatientVoice
https://t.co/KMEwBxW8Cm
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🚨 FDA finalizes amendments to prior notice regulation for imported food: Requires mail service name & tracking # for international shipments • Sets timeframes for post-refusal/post-hold submissions• Enhances food safety & import tracking. https://t.co/l5JDNjUDc9
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🤝 Closing tomorrow! Cancer researchers, patients & advocates: share research ideas with FDA Oncology. Your question could become a pooled analysis study - with you as a collaborator on design, analysis & publication. Deadline: Sept 26 https://t.co/bFqlC7vCr9
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Additional products have been added to the safety alert. https://t.co/eO87TdXJj5 Consumers should not eat, sell, or serve recalled products.
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As part of the agency’s commitment to reinforce radical transparency to ensure Americans know what is in their food and that it is safe to eat, consumers will now have access to two new resources for sharing information once an outbreak investigation has been concluded.
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Real-world data (RWD)/real-world evidence (RWE) can advance the development of drugs and biological products & strengthen their oversight. Now available: an FDA webpage with examples showing how FDA uses RWE to inform regulatory decision-making. https://t.co/eeKosGJtyQ
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RT @US_FDA: 💡 How does real-world evidence (RWE) inform regulatory action? Discover FDA examples on our new RWE webpage, launching ahead of…
healthpolicy.duke.edu
The 21st Centuries Cure Act of 2016 focused on accelerating medical product development to deliver innovations faster and more efficiently to patients. Real-world data (RWD) and real-world evidence...
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Join CBER’s Office of Vaccines Research and Review (OVRR) on October 23, 2025, for up-to-date information about the diagnosis of allergic contact dermatitis using patch tests. Register: https://t.co/mFGpb7sjN5
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#DYK sickle cell disease (SCD) may cause delayed puberty & is also associated with reproductive complications, including #preeclampsia & infants with low birth weight? Find out more about SCD & how it impacts women. https://t.co/9Go9oCbeV9
#NationalSickleCellAwarenessMonth
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