FDA approves novel device for treating breathing difficulty from severe emphysema - FDA Press Releases

FDA approves novel device for treating breathing difficulty from severe emphysema

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LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement - FDA Safety Alerts & Drug Recalls

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling certain lots of Prescript-Assist, a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, dairy, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

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Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing - FDA Safety Alerts & Drug Recalls

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if they consume this product. If you are not allergic to milk or egg, this product is safe to eat. No illnesses have been reported to date. The Food and Drug Administration has been made aware of this recall.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to advance health through improvements in nutrition under the agency’s Nutrition Innovation Strategy - FDA Press Releases

Announcement of public meeting to solicit input on plans to modernize food standards and labeling

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Macrolide and phenolic metabolites from the marine-derived fungus Paraconiothyrium sp. VK-13 with anti-inflammatory activity - Journal of Antibiotics

Macrolide and phenolic metabolites from the marine-derived fungus Paraconiothyrium sp. VK-13 with anti-inflammatory activity

Macrolide and phenolic metabolites from the marine-derived fungus <i>Paraconiothyrium</i> sp. VK-13 with anti-inflammatory activity, Published online: 26 June 2018; doi:10.1038/s41429-018-0073-8

Macrolide and phenolic metabolites from the marine-derived fungus Paraconiothyrium sp. VK-13 with anti-inflammatory activity

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Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components - FDA Press Releases

FDA Commissioner Scott Gottlieb, M.D., discusses the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components.

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FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy - FDA Press Releases

FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.

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FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients - FDA Press Releases

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

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Staurosporine: new lease of life for parent compound of today’s novel and highly successful anti-cancer drugs - Journal of Antibiotics

Staurosporine: new lease of life for parent compound of today’s novel and highly successful anti-cancer drugs

Staurosporine: new lease of life for parent compound of today’s novel and highly successful anti-cancer drugs, Published online: 22 June 2018; doi:10.1038/s41429-018-0029-z

Staurosporine: new lease of life for parent compound of today’s novel and highly successful anti-cancer drugs

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Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

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Golden Star Wholesale Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour - FDA Safety Alerts & Drug Recalls

Golden Star Wholesale of Troy, MI 48084 is recalling, AL Reef Dried Apricots Sour, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply - FDA Press Releases

FDA releases draft guidance to help food manufacturers implement the Intentional Adulteration rule under the FDA Food Safety Modernization Act

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Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement.

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Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

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Biosynthetic studies on teleocidins in Streptomyces - Journal of Antibiotics

Biosynthetic studies on teleocidins in Streptomyces

Biosynthetic studies on teleocidins in <i>Streptomyces</i>, Published online: 14 June 2018; doi:10.1038/s41429-018-0069-4

Biosynthetic studies on teleocidins in Streptomyces

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making - FDA Press Releases

FDA issues draft guidance on collecting patient experiences to inform the development and evaluation of medical products

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections - FDA Press Releases

The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

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An Approach to the Older Patient in the Emergency Department - Geriatrics

Older patients in the emergency department (ED) present unique diagnostic and therapeutic challenges. The ED clinicians must simultaneously evaluate and treat older adults along multiple domains: cognitive impairment, atypical presentations, functional impairment, medication management, trauma and falls, and end-of-life care. This article reviews these domains and suggests strategies for a more comprehensive, patient-centered ED approach to older patients. Incorporating assessment of these domains into the ED process improves patient outcomes, provider satisfaction, and ED flow.

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CMS Opioids Roadmap - CMS Blog

Although some progress has been made in efforts to combat the opioid epidemic, the latest data from the Centers for Disease Control and Prevention indicate the crisis is not slowing down. However, it is important for our beneficiaries across the country to know that the Centers for Medicare & Medicaid Services (CMS) is exploring all of our options to address this national crisis.

As evidence of our commitment to the health and well-being of patients, CMS is publishing a roadmap outlining our efforts to address this issue of national concern. In this roadmap, we detail our three-pronged approach to combating the opioid epidemic, focusing in on prevention of new cases of opioid use disorder (OUD), the treatment of patients who have already become dependent on or addicted to opioids, and the utilization of data from across the country to target prevention and treatment activities.

Current estimates show that over two million1 people suffer from opioid use disorder, with a prevalence in Medicare of 6 out of every 1,000 beneficiaries.2 In order to decrease that number, it is crucial that Medicare beneficiaries and providers are aware that there are options available for both prevention of developing new cases of OUD and the treatment of existing cases. CMS is working to ensure that beneficiaries are not inadvertently put at risk of misuse by closely monitoring prescription opioid trends, strengthening controls at the time of opioid prescriptions, and encouraging healthcare providers to promote a range of safe and effective pain treatments, including alternatives to opioids. We are also working on communications with beneficiaries to explain the risks of prescription opioids and how to safely dispose of them, so they are not misused by others. These are just some of the ways we are looking to protect and care for people with Medicare.

1 https://www.hhs.gov/opioids/about-the-epidemic/index.html

2 https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse-Strategy-2016.pdf

CMS also recognizes that the opioid epidemic has affected people covered by Medicaid across the country in different ways – an estimated 8.7 out of 1,000 Medicaid beneficiaries are impacted by OUD. We believe one crucial effort to help on the treatment front is encouraging states to tailor programs to their populations by taking advantage of flexibilities that are available through Medicaid Section 1115 substance use disorder (SUD) demonstrations that improve OUD treatment. CMS has worked with seven new states since October 2017 to approve waivers to tackle the opioid epidemic in their state. With each state having a unique population, we recognize the challenges that states face in creating programs to help, and we are committed to providing the support necessary to help states achieve positive results for their populations.

Beyond Medicare and Medicaid, CMS is also looking across our other programs to use all the tools at our disposal to address the opioid crisis. We are working to ensure that the private plans offering coverage on the Health Insurance Exchanges also provide options for treating OUD, and we are examining our quality standards across our programs to encourage providers to follow best practice guidelines related to opioid misuse diagnosis and treatment. Further, while we have initiatives specific to Medicare and Medicaid, we are also reviewing all of our programs to find solutions that are working at the local level with states, providers, and payers so that we can

disseminate successful ideas as quickly as possible to help our partners know that they do not have to solve this alone.

CMS believes we can make progress in addressing the many aspects of the opioid epidemic in partnership with states and other stakeholder organizations. Every day this crisis claims the lives of loved ones and, in many areas in our country, we have yet to turn the tide. This roadmap is only a start, and as we begin to implement many of our plans and programs, it will continue to evolve. But the roadmap is also a demonstration of CMS’ commitment to explore and offer viable options to address the crisis, to share the information we collect with other agencies and organizations, and to protect our beneficiaries and communities affected by the crisis.

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Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

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Prenylated indole alkaloids from co-culture of marine-derived fungi Aspergillus sulphureus and Isaria felina - Journal of Antibiotics

Prenylated indole alkaloids from co-culture of marine-derived fungi Aspergillus sulphureus and Isaria felina

Prenylated indole alkaloids from co-culture of marine-derived fungi <i>Aspergillus sulphureus</i> and <i>Isaria felina</i>, Published online: 08 June 2018; doi:10.1038/s41429-018-0072-9

Prenylated indole alkaloids from co-culture of marine-derived fungi Aspergillus sulphureus and Isaria felina

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Instability of the 16S rRNA methyltransferase-encoding npmA gene: why have bacterial cells possessing npmA not spread despite their high and broad resistance to aminoglycosides? - Journal of Antibiotics

Instability of the 16S rRNA methyltransferase-encoding npmA gene: why have bacterial cells possessing npmA not spread despite their high and broad resistance to aminoglycosides?

Instability of the 16S rRNA methyltransferase-encoding <i>npmA</i> gene: why have bacterial cells possessing <i>npmA</i> not spread despite their high and broad resistance to aminoglycosides?, Published online: 08 June 2018; doi:10.1038/s41429-018-0070-y

Instability of the 16S rRNA methyltransferase-encoding npmA gene: why have bacterial cells possessing npmA not spread despite their high and broad resistance to aminoglycosides?

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Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

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FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act - FDA Press Releases

FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act

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FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales - FDA Press Releases

FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

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FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products - FDA Press Releases

FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

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A New Era of Accountability and Transparency in Medicaid - CMS Blog

By: Administrator, Seema Verma, Centers for Medicare & Medicaid Services

In his first 500 days in office, President Donald J. Trump has achieved results both at home and abroad for the American people, working to ensure government is more accountable to the American people. One of the many promises the Trump Administration has made and kept is improving accountability and transparency in Medicaid.

Medicaid provides healthcare for more than 75 million Americans, including many of our most vulnerable citizens, at an annual cost of over $558 billion. It has grown significantly over the years, consuming an every greater share of our public resources – from 10 percent of state budgets in 1985 to nearly 30 percent in 2016. Medicaid should improve the lives of those it serves by delivering high quality health care and services to eligible individuals at a maximum value to American taxpayers. As the administrators of the program, states, along with their local healthcare professionals who care for their neighbors, know best the unique healthcare needs of their community. Our success on delivering on Medicaid’s promise hinges on the critical role they play in managing the precious state and federal resources with which we are entrusted.

That’s why we have committed to resetting the state-federal partnership by ushering in a new era of state flexibility. We’ve approved groundbreaking Medicaid demonstration projections, including reforms to test how Medicaid can be designed to improve health outcomes and lift individuals from poverty by connecting coverage to community engagement. We are streamlining our internal processes and breaking down regulatory barriers that force states to commit too much of their time and resources to administrative tasks rather than focusing on delivering better care.

But with that commitment to flexibility must come an equal pledge to improve transparency and accountability. Too often we have struggled to articulate our collective performance in executing on our immense responsibility. This is best reflected in the fact that Medicaid is responsible for approximately half of the nation’s births, yet no one will argue that we are achieving the birth outcomes our future generations deserve. As we return power to states, we must shift our oversight role at CMS to one that focuses less on process and more on holding us all collectively accountable for achieving positive outcomes.

That is precisely why, last November, I announced that we would create the first ever CMS Medicaid and CHIP Scorecard to increase public transparency about the programs’ administration and outcomes. The data offered within the Scorecard begins to offer taxpayers insights into how their dollars are being spent and the impact those dollars have on health outcomes.  The Scorecard includes measures voluntarily reported by states, as well as federally reported measures in three areas: state health system performance; state administrative accountability; and federal administrative accountability. As states continue to seek greater flexibility from CMS, the Scorecard will serve as an important tool in ensuring that CMS is able to report on critical outcome metrics.

The first version of the Scorecard is foundational to CMS’s ongoing efforts to enhance Medicaid and CHIP transparency and accountability. We’ve begun this initiative by publishing selected health and program indicators that include measures from the CMS Medicaid and CHIP Child and Adult Core Sets along with federal and state accountability measures. For the first time, we are publicly publishing measures that show how we are doing in the business of running these immense programs, including things like how quickly we review state managed care rate submissions or approve state section 1115 Medicaid demonstration projects. Our stakeholders, including beneficiaries, providers, and advocates, deserve to have this information available to them.

And we’re just getting started. Public reporting of meaningful quality and performance metrics is an important and ongoing responsibility of states and the federal government given Medicaid’s vital role in covering nation’s children and as the single greatest payer for long-term care services for the elderly and people with disabilities.

That’s why, in future years, the Scorecard will be updated annually with new functionality and new metrics as data availability improves, including measures that focus on program integrity as well as opioid and home and community-based services quality metrics. Over time, we plan to add the ability for users of the Scorecard to generate year-to-year comparisons on key metrics, as well as to compare states on measures of cost and program integrity. While some variation may be inherent based on geographic, population, reporting or programmatic differences, the public should have access to information that allows them to understand how and why costs and outcomes can vary from state to state for the same populations. Then we can begin to ask important questions about what may really be driving differences in quality and efficiency.

CMS recognizes that continued insight from our state partners is a critical component in the maintenance of the Scorecard. I want to thank all the states for their assistance in the creation of this first iteration, particularly the 14 states that served on the National Association of Medicaid Director’s workgroup over the last six months. Many of the measures are only possible because of the commitment from states to collect and report on these important metrics.  Through this partnership with states, CMS will continue to advance policies and projects that increase flexibility, improve accountability and enhance program integrity and are designed to fulfill Medicaid’s promise to help Americans lead healthier, more fulfilling lives.

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Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter - FDA Safety Alerts & Drug Recalls

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office - FDA Press Releases

FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs.

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SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags - FDA Safety Alerts & Drug Recalls

On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences. There have been no reported injuries to date.

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