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Valisure, LLC, New Haven FEI3012063246 page2 Section 582(c)(4) and (d)(4) of the FD&C Act establishes the DSCSA’s verification requirements for wholesale distributors and dispensers respectively ... . Maia ozawa

Feb 16, 2023 · Images: Reuters/AFP/Getty Images Composite: Mark Kelly. Claims by the small laboratory company, Valisure LLC, that popular consumer products contain cancer-causing chemicals have generated ... Sep 28, 2018 · Valisure is the first online Analytical Pharmacy to chemically batch-validate medications and is committed to ensuring the safety, quality and consistency of the medications it delivers to consumers. Valisure generates some of the most impactful laboratory analyses in the pharmaceutical industry, has a talented staff, and is a highly engaging place to work. Our company is growing and expanding each year, which will provide new and challenging opportunities for every employee. With the growth of our company each year, there are always new ...On March 2, 2020, Valisure announced its detection of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Of the 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA ...Images: Reuters/AFP/Getty Images Composite: Mark Kelly. Claims by the small laboratory company, Valisure LLC, that popular consumer products contain cancer-causing chemicals have generated ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...May 27, 2021 · A new study by Valisure found that 78 sunscreens contain benzene, a known human carcinogen, which means it could cause cancer and other potentially serious health problems. May 27, 2021 · A new study by Valisure found that 78 sunscreens contain benzene, a known human carcinogen, which means it could cause cancer and other potentially serious health problems. Ranitidine molecule. “Beyond Valisure’s tests, the presence of NDMA in ranitidine is supported by decades of scientific studies at institutions around the world starting as early as 1982. The data published today adds to a growing body of research that raises serious concern regarding ranitidine and its potential to form the potent ...Consumer Reports took a detailed look at our detections of benzene in multiple consumer products in an article, “Benzene, a Known Carcinogen, Has Been Found in Some Spray Sunscreens, Deodorants, and Other Products.”. View the full article via Consumer Reports here. Back to Newsroom. Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ...Aug 8, 2023 · Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot Study NEW HAVEN, Conn., Aug. 8, 2023 /PRNewswire/ -- Valisure has ... Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ...March 24, 2021. On March 24th, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans according to the U.S ...Valisure, the lab that made findings about benzene in samples of Artnaturals sanitizer and other brands, had submitted a citizen petition in March asking the FDA to take action on Artnaturals and...Valisure and GOJO Industries (makers of Purell), investigated the quality of bulk hand sanitizers during the pandemic and published the study: The presence of unsafe chemical impurities accelerated evaporation of alcohol, and lack of crucial labeling requirements are risks and concerns for some alcohol-based hand sanitizers and dispenser practices during the COVID-19 pandemic.Description. Developer of laser-induced quantum shift emissions-based technology designed to address the variability and quality problems that pervade many pharmaceutical products throughout the United States. The company's technology focuses on patient advocacy, consumer protection, and performing advanced research and development that is ...Valisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order to generate objective drug quality data through independent sourcing and chemical testing. Below is a brief overview, background and overarching objective of this pharmaceutical quality risk assessment pilot study ...Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in SunscreensValisure, a pharmacy that batch tests medication before it reaches consumers, tested 294 different batches of sun care products from 69 different companies (find the full results here, on page 12).September 13, 2019. On September 13, 2019, Valisure announced they discovered the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication and filed a detailed petition with the Food and Drug Administration asking the agency to recall all products containing ranitidine.Consumer Reports took a detailed look at our detections of benzene in multiple consumer products in an article, “Benzene, a Known Carcinogen, Has Been Found in Some Spray Sunscreens, Deodorants, and Other Products.”. View the full article via Consumer Reports here. Back to Newsroom.September 13, 2019. On September 13, 2019, Valisure announced they discovered the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication and filed a detailed petition with the Food and Drug Administration asking the agency to recall all products containing ranitidine.Valisure investigated further mechanisms relevant to the conditions in the human body and identified a broadly expressed enzyme, DDAH-1, which is known to cleave DMA from its substrate and release it, presenting a known risk of NDMA formation. 4 Valisure’s computational modelling suggest this enzymeValisure’s November 1, 2022, Citizen Petition on benzene contamination in dry shampoo was announced exclusively via Bloomberg in an article titled, " Cancer-Causing Toxin Found in Dry Shampoos Still on Store Shelves, Study Shows. " National healthcare reporter Anna Edney tells the story of how Valisure tested 148 batches from 34 brands of dry ...Nov 1, 2022 · Valisure’s November 1, 2022, Citizen Petition on benzene contamination in dry shampoo was announced exclusively via Bloomberg in an article titled, " Cancer-Causing Toxin Found in Dry Shampoos Still on Store Shelves, Study Shows. " National healthcare reporter Anna Edney tells the story of how Valisure tested 148 batches from 34 brands of dry ... Consumer Reports took a detailed look at our detections of benzene in multiple consumer products in an article, “Benzene, a Known Carcinogen, Has Been Found in Some Spray Sunscreens, Deodorants, and Other Products.”. View the full article via Consumer Reports here. Back to Newsroom.Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the “inherent instability” of the ranitidine molecule. This means that all manufacturers, brands or generic, and all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body.Ranitidine molecule. “Beyond Valisure’s tests, the presence of NDMA in ranitidine is supported by decades of scientific studies at institutions around the world starting as early as 1982. The data published today adds to a growing body of research that raises serious concern regarding ranitidine and its potential to form the potent ...In the laboratory test conducted by Valisure, 294 unique batches of sun care products from 69 different companies were examined. Results of the test found 27% of samples tested contained detectable benzene, while some batches contained up to 3 times the FDA concentration limit of 2 parts per million (ppm).Nov 1, 2022 · In Valisure’s study, three batches from one brand contained benzene levels of more than 100 ppm, while 11 batches from three other brands contained more than 20 ppm. Even more products were ... Valisure, a New Haven, Connecticut-based analytical laboratory, tested 148 batches from 34 brands of spray-on dry shampoo and found that 70% contained benzene. The chemical can cause certain blood ...Shortly after Valisure reported that it had found benzene in hand sanitizer, the FDA spent several weeks combing through the lab’s facilities and ultimately accused it of operating without ...Ranitidine molecule. “Beyond Valisure’s tests, the presence of NDMA in ranitidine is supported by decades of scientific studies at institutions around the world starting as early as 1982. The data published today adds to a growing body of research that raises serious concern regarding ranitidine and its potential to form the potent ... Valisure is registered with the Drug Enforcement Administration (License # RV0484814). Valisure’s mission is to help ensure the safety, quality and consistency of medications and supplements in the market. In response to rising concerns about counterfeit medications, generics, and overseas manufacturing, Valisure developed proprietary analyticalSep 28, 2018 · Valisure is the first online Analytical Pharmacy to chemically batch-validate medications and is committed to ensuring the safety, quality and consistency of the medications it delivers to consumers. Here's a list of brands, manufacturers and sunscreens with benzene, according to Valisure: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Lotion, SPF 50 Babyganics Kid's Sunscreen ...May 27, 2021 · A new study by Valisure found that 78 sunscreens contain benzene, a known human carcinogen, which means it could cause cancer and other potentially serious health problems. Nov 1, 2022 · In Valisure’s study, three batches from one brand contained benzene levels of more than 100 ppm, while 11 batches from three other brands contained more than 20 ppm. Even more products were ... Photo: Getty Images. Last spring, Valisure, a small Connecticut lab, announced that it had found benzene, a known carcinogen, in Neutrogena spray sunscreens. The findings prompted Johnson ...Valisure, LLC. 5 Science Park, New Haven, CT 06511, 833-825-4787, www.valisure.com . May 24, 2021 . Division of Dockets Management . Food and Drug Administration . 5630 Fishers Lane, Room 1061 . Rockville, MD 20852 . Re: Valisure Citizen Petition on Benzene in Sunscreen and After-sun Care Products . Dear Sir or Madam:Valisure, a New Haven, Connecticut-based analytical laboratory, tested 148 batches from 34 brands of spray-on dry shampoo and found that 70% contained benzene. The chemical can cause certain blood ...Ranitidine molecule. “Beyond Valisure’s tests, the presence of NDMA in ranitidine is supported by decades of scientific studies at institutions around the world starting as early as 1982. The data published today adds to a growing body of research that raises serious concern regarding ranitidine and its potential to form the potent ...Nov 4, 2021 · NEW HAVEN, CT – NOVEMBER 4, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of antiperspirant body sprays, which are considered drug products by the Food and Drug Administration (FDA), as well as in deodorant body spray products, which FDA generally regulates as ... Valisure Signs Agreement With Department Of Defense To Independently Test & Quality Score Drugs. Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot Study. August 8, 2023. -. PR Newswire.Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ...Concerns about sunscreen safety, many entirely unfounded, continue to bubble up. The latest are stemming from a study by Valisure, an independent, for-profit pharmacy and research testing lab ...May 25, 2021 · NEW HAVEN, CT – MAY 25, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which are generally regulated by FDA as cosmetics. Send us a message. Thank you for your interest in Valisure. Please know that we read all the messages sent to us. However, you may not get a personal reply due to the large volume of messages we receive. Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in SunscreensAug 11, 2021 · Here's a list of brands, manufacturers and sunscreens with benzene, according to Valisure: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Lotion, SPF 50 Babyganics Kid's Sunscreen ... Mar 24, 2021 · NEW HAVEN, CT – MARCH 24, 2021 – Valisure has tested and detected benzene, a known human carcinogen, in several batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA). Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in Sunscreens Valisure’s hand sanitizer analysis found the highest levels of benzene in small brands that popped up as demand for the product spiked. Out of 260 samples from 168 brands sold on Amazon, at ...Valisure notes that many dry shampoo products tested had no detectable level of benzene, so it appears that such products can adhere to strict limits. N-nitrosamines. Valisure detected N-Nitrosamines like “NDMA” in multiple drug products, which were followed by broad recalls of ranitidine (Zantac), metformin, and other drugs. Although the ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure Signs Agreement With Department Of Defense To Independently Test & Quality Score Drugs Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot StudySep 28, 2018 · Valisure is the first online Analytical Pharmacy to chemically batch-validate medications and is committed to ensuring the safety, quality and consistency of the medications it delivers to consumers. May 12, 2022 · Photo: Getty Images. Last spring, Valisure, a small Connecticut lab, announced that it had found benzene, a known carcinogen, in Neutrogena spray sunscreens. The findings prompted Johnson ... Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ...Dermatology Times | Valisure Highlights Controversy of Benzene Contamination in Sunscreen Products. Dermatology Times spoke with Valisure's CEO, David Light, regarding the presence of benzene in multiple brands of sunscreen and to discuss the reports' findings and the impact this news will have on the sun protection industry. Watch the full ...Valisure is registered with the Drug Enforcement Administration (License # RV0484814). Valisure’s mission is to help ensure the safety, quality and consistency of medications and supplements in the market. In response to rising concerns about counterfeit medications, generics, and overseas manufacturing, Valisure developed proprietary analyticalValisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order to generate objective drug quality data through independent sourcing and chemical testing. Below is a brief overview, background and overarching objective of this pharmaceutical quality risk assessment pilot study ...Ranitidine molecule. “Beyond Valisure’s tests, the presence of NDMA in ranitidine is supported by decades of scientific studies at institutions around the world starting as early as 1982. The data published today adds to a growing body of research that raises serious concern regarding ranitidine and its potential to form the potent ... Bloomberg’s The Big Take Feature Story: A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind. National healthcare reporter, Anna Edney, covers in an in-depth article how in just 3 years, Valisure's quest to hunt down cancer-causing chemicals in everyday products has impacted pharmaceuticals and consumer goods in markets worth an estimated $9 billion that touch the lives of ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the “inherent instability” of the ranitidine molecule. This means that all manufacturers, brands or generic, and all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body. Concerns about sunscreen safety, many entirely unfounded, continue to bubble up. The latest are stemming from a study by Valisure, an independent, for-profit pharmacy and research testing lab ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Nov 4, 2022 · Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ... Consumer Reports took a detailed look at our detections of benzene in multiple consumer products in an article, “Benzene, a Known Carcinogen, Has Been Found in Some Spray Sunscreens, Deodorants, and Other Products.”. View the full article via Consumer Reports here. Back to Newsroom. Valisure is a partner for quality that is paving the way for increased transparency and quality assurance throughout the healthcare industry. Our novel approach to independent quality assurance has an immense global impact that drives revisiting and improving the pharma and consumer products ecosystem. Given the substantial and alarming concerns within the healthcare ecosystem, Valisure is ...Valisure analyzed 260 bottles from 168 brands. They found 17% of the samples contained detectable levels of benzene. And 21 bottles (8% of the samples) contained levels of benzene that were above ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Valisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order to generate objective drug quality data through independent sourcing and chemical testing. Below is a brief overview, background and overarching objective of this pharmaceutical quality risk assessment pilot study ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... In 2021, Valisure sold its pharmacy subsidiary to a pharmacy chain and continued to work with pharmacies and other stakeholders throughout the healthcare industry to incorporate the benefits of independent quality assurance. Valisure’s November 1, 2022, Citizen Petition on benzene contamination in dry shampoo builds upon the growing list of ... David Light, Chief Executive Officer of Valisure, is a biotech entrepreneur and scientist with over 15 years of broad experience in the field. A graduate of Yale University, David studied molecular biology and has worked in various scientific and business roles at start-ups like Synthetic Genomics, Ion Torrent, and Valisure. Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in SunscreensNov 4, 2022 · Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ... Images: Reuters/AFP/Getty Images Composite: Mark Kelly. Claims by the small laboratory company, Valisure LLC, that popular consumer products contain cancer-causing chemicals have generated ...August 9, 2023 at 9:27 AM PDT. The US Department of Defense entered an agreement with Valisure, an independent lab that’s spotted dangerous chemicals in a variety of widely used pharma and ...Valisure's novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and ...We at Valisure have been appreciative of our association with Congressman Rosa DeLauro over the years. Rosa DeLauro is the Congresswoman from Connecticut’s Third Congressional District and strongly believes in the power of biomedical research and is working to increase funding to make lifesaving breakthroughs in science and medicine.Aug 8, 2023 · Valisure's novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and ... Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ...

Nov 4, 2022 · Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ... . When does chili

Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in Sunscreens Valisure also reported that 14 sun care product lots with some of the highest contaminations are sold across four different popular brands — Neutrogena, Sun Bum, CVS Health and Fruit of the Earth.Aug 11, 2021 · Here's a list of brands, manufacturers and sunscreens with benzene, according to Valisure: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Lotion, SPF 50 Babyganics Kid's Sunscreen ... On November 1, 2022, Valisure announced the detection of high levels of benzene, a known human carcinogen, in several brands and batches of dry shampoo products, which are regulated as cosmetic products by the Food and Drug Administration (FDA). Valisure analyzed 148 unique batches from 34 different brands using industry-standard GC-MS ...On November 1, 2022, Valisure announced the detection of high levels of benzene, a known human carcinogen, in several brands and batches of dry shampoo products, which are regulated as cosmetic products by the Food and Drug Administration (FDA). Valisure analyzed 148 unique batches from 34 different brands using industry-standard GC-MS ...Oct 26, 2022 · "Unfortunately the more we looked, the more we found," he said of Valisure's tests, which late last year petitioned the FDA for product recalls after it detected benzene in 54% of the 108 batches ... A 2021 report detected benzene in 78 different popular sunscreens and after-sun products. Valisure, a pharmacy that tests its own products, tested nearly 300 sprays and lotions. Benzene, a carcinogen, was detected in 27% of samples. Some batches contained up to three times the restricted Food and Drug Administration (FDA) concentration limit of ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Sarah D. Young, Reporter and Editor. • Mar 30, 2021. Some hand sanitizers have elevated levels of the human carcinogen Benzene, according to a new study conducted by Valisure, an independent ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more.Valisure is a partner for quality that is paving the way for increased transparency and quality assurance throughout the healthcare industry. Our novel approach to independent quality assurance has an immense global impact that drives revisiting and improving the pharma and consumer products ecosystem. Given the substantial and alarming concerns within the healthcare ecosystem, Valisure is ...Jan 10, 2020 · A car on a hot summer day could reach 140 F.) Valisure reported the results to the FDA, which took exception to the testing methods, saying that its testing at lower temperatures had resulted in ... Valisure, LLC. 5 Science Park, New Haven, CT 06511, 833-825-4787, www.valisure.com . May 24, 2021 . Division of Dockets Management . Food and Drug Administration . 5630 Fishers Lane, Room 1061 . Rockville, MD 20852 . Re: Valisure Citizen Petition on Benzene in Sunscreen and After-sun Care Products . Dear Sir or Madam:Nov 30, 2021 · In early November, Valisure issued a citizen petition to the FDA stating that its testing revealed benzene was present at up to nine times the emergency FDA limit of 2 parts per million in several ... May 27, 2021 · A new study by Valisure found that 78 sunscreens contain benzene, a known human carcinogen, which means it could cause cancer and other potentially serious health problems. Valisure, a pharmacy that batch tests medication before it reaches consumers, tested 294 different batches of sun care products from 69 different companies (find the full results here, on page 12).Valisure is a partner for quality that is paving the way for increased transparency and quality assurance throughout the healthcare industry. Our novel approach to independent quality assurance has an immense global impact that drives revisiting and improving the pharma and consumer products ecosystem. Given the substantial and alarming concerns within the healthcare ecosystem, Valisure is ... .

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