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Silver Spring, MD
Joined October 2010
The FDA today launched the Rare Disease Framework Initiative to reimagine rare disease drug development. The new framework will adapt aspects of the agency’s long-standing approach designed for larger diseases. It will adopt an optimized, fit-for-purpose framework for rare disease drug development that considers the nuances of a specific disease, patient needs, product type, and attainable evidence. fda.gov/news-events/press-an… FDA will host a meeting on Oct. 28 at the White Oak campus to collect feedback on the Rare Disease Framework Initiative from patients, disease advocates, industry, and other stakeholders. fda.gov/news-events/fda-meet…
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FDA’s #PrescribeWithConfidence campaign supports the Trump Administration’s Great American Recovery Initiative by helping expand access to evidence-based treatment for #OpioidUseDisorder. fda.gov/drugs/drug-safety-an… Watch the final four videos in the 10-part series featuring nurse practitioner Amy Techau: youtube.com/playlist?list=PL…
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Don't miss this! Register today for the FDA Grand Rounds on Oct. 22. CDRH experts will take you inside FDA's Real-World Evidence Program & its role in digital health technology. Attend in person or tune in via webcast. FDA.gov/GrandRounds
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U.S. FDA retweeted
Recalled fresh jalapeños from Sinaloa, Mexico, distributed by Coast Citrus Distributors, are no longer for sale and are past shelf life. Check your home and discard recalled jalapeños or return them for a refund.
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News: @FDA approved a new long-acting insulin taken once a week for adults with type 2 diabetes to help manage their blood sugar along with diet and exercise. fda.gov/drugs/news-events-hu…
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During public health emergencies, the FDA’s Center for Devices and Radiological Health supports the development and evaluation of critical medical countermeasures to address emerging threats and meet urgent public health needs. Emergencies can happen at any time. Taking a few steps now can help you stay safe and keep  your medical devices working when you need them most. fda.gov/emergency-preparedne… #NationalPreparednessMonth
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🔥 @realchefrush has entered the kitchen. An all-new episode of #TheRealFoodShow is LIVE, only on YouTube. Watch now and subscribe: youtu.be/3wZ7NhUYrh0
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Mark your calendars: The FDA will hold a public meeting on Nov. 19 of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The Committee will meet to discuss and provide recommendations to the Agency on the use of pathogen-agnostic sequencing for emergency preparedness and response efforts. A public docket is open. Learn more and submit comments: fda.gov/advisory-committees/…
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Twenty-five years ago, our nation was forever changed. Today, we remember the nearly 3,000 lives taken on September 11, 2001, and honor the first responders who ran toward danger to save others. In the days and weeks that followed, HHS joined the response, including the @usphscc and personnel from the National Disaster Medical System and the National Pharmaceutical Stockpile, which would later become important parts of @ASPRgov. We honor all who served, all who sacrificed, and all who still carry the wounds of that day. We will never forget. 🇺🇸
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🎒 We’re putting artificial colors on recess! Food manufacturers and industry groups have committed to removing certified petroleum-based colors from a range of K-12 foods. See who’s making changes and track the progress: fda.gov/food/color-additives…
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U.S. FDA retweeted
Consumers should check their refrigerators for recalled broccoli sprouts grown by Evergreen Fresh Sprouts, LLC and should throw them away.
🤖 Made with AI
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Nearly half of U.S. counties have ZERO cardiologists. Millions of Americans have no access to cardiovascular care. And every year, there are 200,00+ preventable deaths from cardiovascular disease. ARPA-H is ending this with ADVOCATE. We’ve picked the teams building an FDA-authorized AI system for real-world heart care. Building toward an AI cardiologist for every American—always ready, clinically trusted, specialist-backed. Not tweaking the old system. Building the next one. Learn more ➡️ arpa-h.gov/explore-funding/p…
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Individualized genetic medicines can be designed in days. Making them still takes months—leaving patients waiting. ARPA-H launched GIVE to rebuild biomanufacturing around the patient. Today we announced the teams building a faster, cheaper, more accessible model for individualized RNA medicines. 🔬 Automated production ✅ Quality checks baked in 🌐 Distributed network across the U.S. Expanding access to treatments for cancer, rare diseases, infections, autoimmune conditions, and more. Learn more and meet the GIVE teams: arpa-h.gov/news-and-events/a…
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Today, as part of the Trump Administration’s ongoing commitment to accelerating lifesaving medical innovations for American patients, we granted accelerated approval to an estrogen receptor antagonist in combination with a CDK4/6 inhibitor for adults with HR+/HER2- locally advanced or metastatic breast cancer with an ESR1 mutation. This expands treatment options for women with advanced breast cancer. fda.gov/news-events/press-an…
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U.S. FDA retweeted
September is National Recovery Month—a time to celebrate recovery and remind Americans struggling with addiction that there is hope. Drawing from her own journey through addiction and recovery, Great American Recovery Co-Chair @KathrynBurgum shares a powerful message: recovery is possible. Under the leadership of @POTUS and @SecKennedy, HHS is working to connect more Americans to treatment and the resources they need to achieve and sustain recovery. Learn more about Great American Recovery and its mission at hhs.gov/recovery.
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Today, the @FDA issued an Emergency Use Authorization for Capstar (Nitenpyram) tablets and has revised the authorization for generic Nitenpyram tablets. Both products are authorized for the prevention and treatment of New World screwworm infestations in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old. Most U.S. pets remain at low risk.
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The @FDA is actively working with all six manufacturers of estradiol transdermal patches to increase supply amid growing demand. While patches remain available, availability may vary by product, pharmacy or location. If you’re affected, please reach out to your pharmacist or healthcare provider to discuss available options. For your safety, do not stop or change your medication without medical guidance.
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SEC 🤝 @FDA 📸 from the MOU signing yesterday to bolster cooperation and ensure market integrity between the SEC and @FDA!
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TODAY🚨: The SEC and the @FDA announced that they have entered into a Memorandum of Understanding (MOU) designed to assist the agencies in carrying out their respective missions of ensuring the integrity of the financial markets and protecting public health.
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U.S. FDA retweeted
FDA's Enforcement Report is sometimes misinterpreted as breaking news or a new recall action, when it's not. Today's report includes the classification for the Taylor Farms de Mexico iceberg lettuce recall related to a Cyclospora outbreak. This is a routine step for food recalls. No new actions have been taken, and the original July 17, 2026, recall notice has not changed. fda.gov/food/hfp-constituent…
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