Fda Health Care Blog

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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/

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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

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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COVID-19 Vaccines FDA - U.S. Food and Drug …

(7 days ago) WEB177 rows · The FDA took the following actions in the agency’s ongoing response to the …

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

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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

Commit to a Healthier Version of You FDA

(2 days ago) WEBOsteoporosis is a disease that causes your bones to get very weak and break easily. The disease can cause severe pain and disability which can affect how you live and get …

https://www.fda.gov/consumers/knowledge-and-news-women-owh-blog/commit-healthier-version-you

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Increasing Options in Research for Medical Product …

(8 days ago) WEBModernizing Clinical Research Oversight. Efficient, well-designed clinical research is a critical element of the FDA’s public health mission to help advance …

https://www.fda.gov/news-events/fda-voices/increasing-options-clinical-research-facilitate-medical-product-development

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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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Knowledge and News on Women: OWH Blog FDA

(7 days ago) WEBContact Point. Food and Drug Administration Office of Women's Health 10903 New Hampshire Ave WO32-2333 Silver Spring, MD 20993. [email protected]. (301) …

https://www.fda.gov/consumers/womens-health/knowledge-and-news-women-owh-blog

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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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FDA Roundup: April 23, 2024 FDA - U.S. Food and Drug …

(7 days ago) WEBThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of …

https://www.fda.gov/news-events/press-announcements/fda-roundup-april-23-2024

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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 part of its push to advance health

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

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FDA approves a new antibacterial drug to treat a serious lung …

(Just Now) WEBThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary …

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

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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 encourage your participation in our discussion and look forward to an active exchange of ideas. Advancing Health Equity in Health Care. In March 1966, Dr. Martin Luther King, Jr. …

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

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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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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

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

FDA Healthcare at Home Initiative Identifies OT as a Key Need

(2 days ago) WEBThe Initiative aims to better position the FDA to address health care needs by moving care into the home setting. Based within the FDA’s Center for Devices and …

https://www.aota.org/about/for-the-media/aota-news/fda-healthcare-at-home-initiative-identifies-ot-as-a-key-need

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Will the FDA get more tools for handling accelerated drug …

(Just Now) WEBThe FDA does have some ability to delay layoffs for about five weeks if the PDUFA reauthorization stalls, Califf told the agency staff. In a memo that the FDA released publicly via Twitter, Califf said there were about five weeks of funding leftover to carry beyond the Sept. 30 cutoff.

https://healthjournalism.org/blog/2022/09/will-the-fda-get-more-tools-for-handling-accelerated-drug-approvals/

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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/

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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 that FDA currently employs many vehicles and authorities to encourage drug development”. The FDA relies upon a serious case of tunnel vision to miss the point.

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

Category:  Medicine Show Health

Advancing digital health: FDA innovation during COVID-19 - PMC

(3 days ago) WEBAbstract. Digital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital health innovation during the …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7747714/

Category:  Food Show Health

What Is the FDA’s Role in Public Health? - Council on Foreign …

(1 days ago) WEBThe Food and Drug Administration (FDA), the United States’ regulatory agency for food, medical, and an array of other products, is a critical part of U.S. public …

https://www.cfr.org/backgrounder/what-fdas-role-public-health

Category:  Food,  Medical Show Health

Information for Health Care Professionals Drugs FDA

(5 days ago) WEBDrug Safety Information and resources for healthcare professionals. Safety. Drug Shortages. Current and resolved drug shortages and discontinuations reported to …

https://www.fda.gov/drugs/resources-drugs/information-health-care-professionals-drugs

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FDA Launches Health Care at Home Initiative

(4 days ago) WEBThe U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) this week announced a new initiative aimed to help reimagine the home …

https://globalbiodefense.com/2024/04/23/fda-launches-health-care-at-home-initiative/

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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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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) extra authority to compel drugmakers to hold up their ends of the bargains struck on accelerated approvals. These are agreements that allow earlier sales of seemingly …

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

Category:  Food 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

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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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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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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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