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FDA Launches Health Care at Home Initiative to Advance …

(5 days ago) WEBToday, the U.S. Food and Drug Administration is announcing the launch of a new initiative, Home as a Health Care Hub, to help reimagine the home environment as …

https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-launches-health-care-home-initiative-help-advance-health-equity

Category:  Food Show Health

Blog: Digital Health Collaboration Fosters Innovation and …

(9 days ago) WEBI see patients, researchers, health care providers, medical product manufacturers, technology companies, standards organizations, and many other …

https://www.fda.gov/medical-devices/digital-health-center-excellence/blog-digital-health-collaboration-fosters-innovation-and-health-equity

Category:  Medical Show Health

FDA Law Update Blog Sheppard Mullin

(7 days ago) WEBDecember 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the …

https://www.fdalawblog.com/

Category:  Health Show Health

The Code is Cracked: Interchangeable Biologics are Here - FDA …

(3 days ago) WEBAn interchangeable “meets additional requirements” for substitution, and “health care providers and patients can be confident in the safety and effectiveness of a …

https://www.thefdalawblog.com/2021/08/the-code-is-cracked-interchangeable-biologics-are-here/

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Cancer Currents: An NCI Cancer Research Blog - NCI

(5 days ago) WEBThe Cancer Currents blog provides news and research led to FDA’s 2023 approval of repotrectinib (Augtyro) for lung cancers with ROS1 fusions have been …

https://www.cancer.gov/news-events/cancer-currents-blog

Category:  Cancer Show Health

FDA Voices FDA - U.S. Food and Drug Administration

(5 days ago) WEBInsights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco.

https://www.fda.gov/news-events/fda-newsroom/fda-voices

Category:  Food,  Medical Show Health

The Work of FDA Continues in Workstreams that …

(9 days ago) WEBRobert M. Califf, M.D. My career has been devoted to evidence based clinical care—many hours in direct patient care convinced me we needed much better …

https://www.fda.gov/news-events/fda-voices/work-fda-continues-thousands-workstreams-americans-and-world-count-every-day

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The digital transformation in health care: The FDA’s …

(3 days ago) WEBThis article describes recent advances in health care devices and focuses on the FDA’s involvement in regulating these devices. Immediately following this summary …

https://www.facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/2021/06/the-digital-transformation-in-health-care-the-fdas-perspective/

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FDA approves a new antibacterial drug to treat a serious …

(Just Now) WEBThe U.S. Food and Drug Administration today approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of …

https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibacterial-drug-treat-serious-lung-disease-using-novel-pathway-spur-innovation

Category:  Food Show Health

FDA seeks feedback on technologies to enable healthcare at home

(6 days ago) WEBThe U.S. Food and Drug Administration is asking for public input on the transition to at-home care and how regulators can support enabling technologies. As …

https://www.healthcaredive.com/news/fda-healthcare-at-home-questions/654453/

Category:  Food Show Health

Health Care FDA Law Blog

(1 days ago) WEBArkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25th, 2024. As drug manufacturers battle the Health Resources and …

https://www.thefdalawblog.com/category/health-care/

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FDA spends $1.2M on VR project to envision at-home care

(2 days ago) WEBThe Food and Drug Administration’s (FDA's) device center launched an initiative to promote at-home medical device development with a focus on health equity …

https://www.fiercehealthcare.com/ai-and-machine-learning/home-medical-devices-field-view-fda

Category:  Food,  Medical Show Health

FDA’s New Draft Guidance on 510(k) Implant Devices: What You …

(8 days ago) WEBThe objectives of the draft guidance are as follows: “Serve as a primary resource on expectations for all 510 (k) implant devices, generally, while device-specific …

https://www.thefdalawblog.com/2023/10/fdas-new-draft-guidance-on-510k-implant-devices-what-you-need-to-know/

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A New Use for Wegovy Opens the Door to Medicare Coverage for …

(4 days ago) WEBThe FDA recently approved a new use for Wegovy, the blockbuster anti-obesity drug, to reduce the risk of heart attacks and stroke in people with cardiovascular …

https://www.kff.org/medicare/issue-brief/a-new-use-for-wegovy-opens-the-door-to-medicare-coverage-for-millions-of-people-with-obesity/

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The FDA’s Culture: Should Safety Dominate All Practices?

(Just Now) WEBThe FDA said that “between 2013 and 2018, 76 out of 240 novel new drugs approved (31.7%) would likely be considered precision medicines…Additionally, we note …

https://thehealthcareblog.com/blog/2021/08/26/the-fdas-culture-should-safety-dominate-all-practices/

Category:  Medicine Show Health

Evaluating concerns about accelerated FDA drug approvals

(9 days ago) WEBThe House in June passed its version of the bill, 392-28, with strong bipartisan support. The House bill would give the Food and Drug Administration (FDA) …

https://healthjournalism.org/blog/2022/09/evaluating-concerns-about-accelerated-fda-drug-approvals/

Category:  Food Show Health

Safe Healthcare Blog Blogs CDC

(7 days ago) WEBCDC - Blogs - Safe Healthcare Blog - The Division of Healthcare Quality Promotion plans to blog on as many healthcare safety topics as possible. We …

https://blogs.cdc.gov/safehealthcare/

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HHS Issues New Rule to Strengthen Nondiscrimination Protections …

(Just Now) WEBDownload the News Release Download the News Release - Word. Today, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) …

https://www.hhs.gov/about/news/2024/04/26/hhs-issues-new-rule-strengthen-nondiscrimination-protections-advance-civil-rights-health-care.html

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The FDA accelerated approval pathway works - STAT

(1 days ago) WEBThe Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need …

https://www.statnews.com/2024/04/23/accelerated-approval-program-fda-cancer-data/

Category:  Food,  Medical Show Health

1 in 5 milk samples from grocery stores test positive for bird flu.

(7 days ago) WEB(SACRAMENTO) The Food and Drug Administration announced Tuesday that samples of pasteurized milk taken from grocery store shelves had tested positive for bird …

https://health.ucdavis.edu/news/headlines/grocery-store-milk-tests-positive-for-bird-flu-why-the-fda-says-its-still-safe-to-drink/2024/04

Category:  Food Show Health

One in Five Milk Samples Nationwide Shows Genetic Traces of Bird …

(4 days ago) WEBDr. Marrazzo cautioned that while the results were a small sample, the findings were “welcome news.” “To really understand the scope here, we need to wait for the …

https://www.nytimes.com/2024/04/25/health/bird-flu-milk-fda.html

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What We Do FDA - U.S. Food and Drug Administration

(Just Now) WEBThe Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological …

https://www.fda.gov/about-fda/what-we-do

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FDA announces the recall of heart pumps linked to - Health …

(8 days ago) WEBA review of the FDA device database shows at least 130 reports related to HeartMate II or 3 that mention the complication reported by regulators. The earliest such …

https://health.wusf.usf.edu/health-news-florida/2024-04-17/fda-announces-the-recall-of-heart-pumps-linked-to-deaths-and-injuries

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FDA & Healthcare Law Blog - Cohen Healthcare Law Group

(6 days ago) WEBMSOs and Compliance Issues for Anti-Aging Aesthetic Clinics. The doctors and owners of anti-aging medical practices need to understand what procedures and treatments …

https://cohenhealthcarelaw.com/blog/

Category:  Medical Show Health

Working Together to Advance Health and Build a Better Future

(3 days ago) WEBStand up. Speak out. Be heard. The stakes for the future of health care are too high to do anything less. That was a key message for the approximately 1,000 …

https://www.aha.org/news/perspective/2024-04-19-working-together-advance-health-and-build-better-future

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US FDA approves ImmunityBio's bladder cancer therapy

(3 days ago) WEBThe U.S. health regulator approved on Monday ImmunityBio's combination therapy to treat a type of bladder cancer, marking an end to the company's efforts to …

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-immunitybios-bladder-cancer-therapy-2024-04-22/

Category:  Cancer Show Health

The Biden-Harris Administration Issues New Rule to Support …

(3 days ago) WEBProhibits the use or disclosure of PHI when it is sought to investigate or impose liability on individuals, health care providers, or others who seek, obtain, …

https://www.hhs.gov/about/news/2024/04/22/biden-harris-administration-issues-new-rule-support-reproductive-health-care-privacy-under-hipaa.html

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Tobacco researchers suggest health care providers talk with adult

(8 days ago) WEBHealth care providers who are working with adult patients struggling to stop smoking should consider discussing e-cigarettes as a potential tool if they’ve already …

https://hollingscancercenter.musc.edu/news/archive/2024/04/16/hollings-tobacco-researchers-healthcare-providers-talk-relative-risks-tobacco-products

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Statement from President Joe Biden on Final Rule to Strengthen …

(4 days ago) WEBThe new protections that my Administration is putting in place are an important step forward in our fight to protect access to reproductive health care and ensure …

https://www.whitehouse.gov/briefing-room/statements-releases/2024/04/22/statement-from-president-joe-biden-on-final-rule-to-strengthen-privacy-protections-for-reproductive-health-care/

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Hearing Wrap Up: FDA Has Stumbled from Crisis to Crisis

(Just Now) WEBUnder the Biden Administration, the FDA has stumbled from crisis to crisis: the infant formula shortages, essential drug shortages, unsafe food, illicit Chinese …

https://oversight.house.gov/release/hearing-wrap-up-fda-has-stumbled-from-crisis-to-crisis%ef%bf%bc/

Category:  Food Show Health

Biden-Harris Administration Partners with States and Releases …

(4 days ago) WEBAs part of the Biden-Harris Administration's Care Workers Recognition Month activities and in support of President Biden's Executive Order on Increasing Access to …

https://www.hhs.gov/about/news/2024/04/25/biden-harris-administration-partners-states-and-releases-data-recommendations.html

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FDA Consumer Warning: Illegal Products Falsely Marketed as

(Just Now) WEBThe Food and Drug Administration (FDA) warned consumers about the potential dangers of using products advertised as dietary supplements that are also …

https://www.njatty.com/blog/fda-consumer-warning-illegal-products-falsely-marketed-as-antimicrobial-dietary-supplements/

Category:  Supplements,  Food Show Health

These highlights do not include all the information needed

(3 days ago) WEBTell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal and dietary supplements. LEVAQUIN ® …

https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=5dd1f9bb-acbf-4deb-9b02-992d52239a6b

Category:  Supplements,  Vitamin,  Medicine Show Health

Cota and Hackensack Meridian Health Announce World-First …

(1 days ago) WEBNEW YORK, Feb. 2, 2017 /PRNewswire/ -- Cota, the leading data and technology platform for value-based precision medicine, and Hackensack Meridian Health (HMH), New …

https://www.prnewswire.com/news-releases/cota-and-hackensack-meridian-health-announce-world-first-partnership-incorporating-complete-digital-map-of-cancer-into-epic-electronic-health-record-system-300401452.html

Category:  Medicine Show Health

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