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🦴 Strong bones support healthy aging. On #WorldOsteoporosisDay, learn how FDA-approved biosimilars may be an option for some bone-related conditions, including certain forms of osteoporosis: Learn more: fda.gov/drugs/biosimilars/ba…
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Food fraud can cost consumers more than money—it can undermine confidence in what’s on the label. FDA testing of 195 domestic and import samples of lemon juice found 7 imported products that did not meet the U.S. standard of identity for lemon juice. This work builds on recent FDA sampling to detect economically motivated adulteration in foods including honey and seafood. Learn more about the results of FDA’s testing of lemon juice samples.
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This #BreastCancerAwarenessMonth, pink ribbons come with real reason for hope. In the past year alone, FDA approved 10 new breast cancer treatments. The FDA is working every day to get life-saving breakthroughs to patients faster. washingtonexaminer.com/op-ed…
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⚠️ FDA is warning consumers about counterfeit OTC eye drops found in Florida and Georgia, with possible distribution in other states. Some products tested positive for bacterial contamination, posing risks of eye infections, injury, and vision problems. FDA is working to identify and remove unlawful products.
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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 is transforming rare disease drug approvals. The new Rare Disease Framework Initiative will work to give patients more voice, give developers more clarity, and eliminate surprises in the regulatory process. bloomberg.com/news/articles/…
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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: piped.video/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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Consumers, parents, and caregivers should stop using any product from Lot 25122bw and either discard it or return it to the place of purchase for a refund.
Pacific Health Sciences Voluntarily Recalls One Lot of Babies' Magic Tea Brand Baby Sleep Gripe Water Dietary Supplement MORE: fda.gov/safety/recalls-marke…
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Join us! We’re conducting a nationwide search to find scientific experts and consumer voices to fill vacancies on our advisory committees. Want to help us make informed decisions about public health? Apply today! fda.gov/advisory-committees/…
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In an article published today, Acting FDA Commissioner Kyle Diamantas and CDER Director Mike Davis discuss an action taken by FDA and the Trump administration to ensure that America's warfighters have access to cutting-edge, lifesaving care. washingtonexaminer.com/op-ed…
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The Request for Information released yesterday opens the door for public and expert perspectives as FDA works toward early-stage clinical trials for ibogaine drug products, marking a meaningful step in bringing these products forward.
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As Acting Commissioner Diamantas and Director Davis write, "it stands as a decisive victory for veterans and a clear testament to an administration committed to helping patients and researchers navigate complex study approaches in the relentless pursuit of medical innovation."
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The FDA is taking decisive action to prevent future Cyclospora outbreaks with the advancement of 10 planned activities ahead of the 2027 growing season to strengthen prevention, enhance surveillance, expand industry outreach, and identify innovative solutions to reduce Cyclospora contamination of fresh produce.
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Transparency isn't just good government — it's how we accelerate innovation and protect public health. Today, FDA released its new Transparency Roadmap, outlining FY26 milestones and FY27 priorities: CRL disclosure, NAMs, food labeling, inspections, and more. fda.gov/news-events/fda-voic…
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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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Today, we approved the first heart valve device designed to grow with children. The Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease can be expanded after surgery to keep pace with growth. The adjustable valve may mean fewer repeat surgeries for children as they get older. fda.gov/news-events/press-an… Congenital heart defects are among the most common types of birth defects in the United States, affecting about 1 in every 100 births. The valve was approved through the premarket approval pathway, the FDA's most rigorous review process for medical devices.
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