Understanding the FDA’s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries

 Understanding the FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries1Tobacco, an age-old addiction, dishes out some chilling, unpleasant facts. Tobacco is the US’ leading cause of preventable deaths. Between four and five percent of the entire American population -some 16 million people -live with diseases associated with smoking. Cigarette smoking consumes close to half a million American lives every year, about an eleventh of whom never smoked, meaning that they are second hand smokers who contract diseases just by being in close physical proximity of smokers. The harmful effects of smoking are such that at this current rate of smoking; seven percent of all Americans who are alive today will die a premature death. The average lifespan of a smoker is a good decade shorter than that of a nonsmoker.

The FDA intervenes strongly

Understanding the FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries3

Given the gravity of this situation; the FDA formulated a landmark law in August 2016, which vastly improved and expanded its powers to regulate smoking. It builds on an earlier ruling, The Family Smoking Prevention and Tobacco Control Act of 2009. The law of 2016 arms the FDA with greater powers to enforce laws on smoking, one of the highlights of which is restricting the sale of tobacco products to minors all over the country, since this population is very vulnerable to exposure to smoking.  The FDA now requires proof of age of the buyer of cigarettes, banning the sale of tobacco products through public vending machines, and prohibiting the distribution of free samples to minors.

Other highpoints of this amended legislation include requiring manufacturers of smokeless tobacco products to enter clearer warning signs on the products, requiring them to disclose the contents; strengthens local and state authority in enforcing these laws, and requires manufacturers to provide scientific proof of claims of moderate risk from these tobacco products.

The amended rule aims at hitting producers of tobacco products hard and brings a wide variety of activities under its regulatory net:

  • Mixing e-liquids
  • Manufacturing or modify any type of vaping device
  • Mixing loose tobacco and making it available to smoke in a pipe
  • Rolling or blending tobacco for cigars
  • Manufacturing loose tobacco that enables consumers to roll their own cigarettes
  • Importing of tobacco products
  • Manufacturing of any tobacco product

The FDA’s regulations on cigarettes and other tobacco products also apply to sellers. The main intention of this modified regulation of August 2016 is that it reviews the ingredients of tobacco products that are sold, the ingredients that go into them, and creates awareness of the dangers of these products, all of which were missing in the earlier legislation.

Learning about all aspects of this regulation

Understanding the FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer a complete explanation of this law. Carolyn Troiano, IT Program Manager and FDA Compliance Consultant, Smart Resources, Inc., who has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, will be the Director of this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

This seminar will describe the best practices for developing a compliance strategy, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.

Understanding the FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries4

She will cover the following areas at this seminar:

  • FDA Tobacco Control Act
  • Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
  • Details of the August 8, 2016 FDA “Deeming” Regulation
  • Pre-Marketing Tobacco Application (PMTA) Submission
  • FDA Oversight and Compliance Strategy
  • Computer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC)
  • Cost vs. Compliance
  • Policies and Procedures
  • Leveraging Vendors
  • Industry Best Practices
  • FDA Trends.

Understanding the FDA’s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries

 

Monitoring the heart’s mitochondria to predict cardiac arrest?

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Credit: Dr. John Kheir, Boston Children’s Hospital & Shutterstock

A new device can assess in real time whether the body’s tissues are receiving enough oxygen and, placed on the heart, can predict cardiac arrest in critically ill heart patients, report researchers at Boston Children’s Hospital and scientists from Cambridge device maker Pendar Technologies. Their study, conducted in animal models, is the cover article in today’s issue of Science Translational Medicine.

 

“With current technologies, we cannot predict when a patient’s heart will stop,” says John Kheir, MD of Boston Children’s Heart Center, who co-led the study. “We can examine heart function on the echocardiogram and measure blood pressure, but until the last second, the heart can compensate quite well for low oxygen conditions. Once cardiac arrest occurs, its consequences can be life-long, even when patients recover.”

The device uses a technology called resonance Raman spectroscopy to measure whether enough oxygen is reaching the mitochondria, the organelles that provide cells with energy. In critically ill patients with compromised circulation or breathing, oxygen delivery is often impaired, making it hard for mitochondria to do their job. This is especially a problem for the heart, which has constant high energy needs.

The current standard for measuring tissue oxygenation, known as mixed venous saturation (SvO2), requires repeated blood draws, adding extra risk in critically ill patients. More importantly, SvO2 cannot tell whether oxygen supply is sufficient to meet the dynamic demands of heart muscle.

“We wanted to create an organ-specific, continuous, reliable readout of how adequately mitochondria are being fed oxygen,” says Kheir. “This is the first demonstration of a device that can monitor mitochondria in living tissues to predict impending organ failure.”

Using light to monitor mitochondria

This technology is the product of a collaboration between the Translational Research Lab in Boston Children’s Heart Center, co-led by Kheir and Brian Polizzotti, PhD, and Pendar Technologies (Cambridge, Mass.). “At the bedside, we saw patients who had a limitation to coronary blood flow, and wanted a device that could provide an early warning sign,” Kheir says.

The team created a metric they call 3RMR that uses light readings generated by resonance Raman spectroscopy to quantify oxygenation and mitochondrial function in real time.

 

Read More: http://snip.ly/bt6o8#https://scienmag.com/monitoring-the-hearts-mitochondria-to-predict-cardiac-arrest-2/

Immune cells may heal bleeding brain after strokes

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Credit: Courtesy of Aronowski lab, University of Texas Health Science Center, Houston.

While immune cells called neutrophils are known to act as infantry in the body’s war on germs, a National Institutes of Health-funded study suggests they can act as medics as well. By studying rodents, researchers showed that instead of attacking germs, some neutrophils may help heal the brain after an intracerebral hemorrhage, a form of stroke caused by ruptured blood vessels. The study suggests that two neutrophil-related proteins may play critical roles in protecting the brain from stroke-induced damage and could be used as treatments for intracerebral hemorrhage.

“Intracerebral hemorrhage is a damaging and often fatal form of stroke for which there are no effective medicines,” said Jaroslaw Aronowski, M.D., Ph.D., professor, department of neurology, at the University of Texas Health Science Center at Houston, and senior author of the study published in Nature Communications. “Our results are a hopeful first step towards developing a treatment for this devastating form of stroke.”

Accounting for 10 to 15 percent of all strokes, intracerebral hemorrhages happen when blood vessels rupture and leak blood into the brain, often leading to death or long-term disability. Chronic high blood pressure is the leading risk factor for these types of strokes. The initial phase of damage appears to be caused by the pressure of blood leaking into the brain. Over time, further damage may be caused by the accumulation of toxic levels of blood products, infiltrating immune cells, and swelling.

 

Decades of research suggest that neutrophils are some of the earliest immune cells to respond to a hemorrhage, and that they may both harm and heal the brain. In this study, the researchers found that interleukin-27 (IL-27), a protein that controls the activity of immune cells, may shift the role of neutrophils from harming the brain to helping with recovery.

Injections of IL-27 after a hemorrhage helped mice recover. Days after the strokes, the treated mice had better mobility, including walking, limb stretching and navigating holes in a floor. In contrast, injections of an antibody that blocked natural IL-27 activity slowed recovery. The brains of the mice treated with IL-27 also showed less damage. They had less swelling around the hemorrhages and lower levels of iron and the blood protein hemoglobin, both of which are toxic at high

Read More: http://snip.ly/5llk8#https://scienmag.com/immune-cells-may-heal-bleeding-brain-after-strokes/

RPS says pharmacists must always be present in pharmacies

The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement.

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Source: Alamy.com

The leaked document, prepared by a working group of the Department of Health’s Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, suggested that current legislation could be changed to allow a registered pharmacy professional, which could include a technician, to take responsibility for the sale and supply of pharmacy and prescription-only medicines.

The Royal Pharmaceutical Society (RPS) has said it believes a pharmacist should always be present in a pharmacy, apart from occasional short periods of time.

Responding to a leaked document produced for the Department of Health (DH) on the issue of whether pharmacy technicians should be allowed to supervise pharmacies, the RPS has issued an eight-point position statement on the role of registered technicians supervising the sale and supply of medicines.

Read More: http://snip.ly/3pujp#http://www.pharmaceutical-journal.com/news-and-analysis/news/rps-says-pharmacists-must-always-be-present-in-pharmacies/20203609.article

FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling. Interoperability of devices can encourage the availability and sharing of information across systems, even when products from different manufacturers are used. A draft of this guidance was issued on January 26, 2016.

The Final Guidance defines “interoperable medical devices” as medical devices “that have the ability to exchange and use information through an electronic interface with another medical/non-medical product, system, or device.” These functions can consist of a one-way data transmission to another device or product, or more complex interactions in which command and control is exercised over another device. An “electronic interface” is defined as the medium by which systems communicate with each other, and includes both the type of connection and the information content.

According to the Final Guidance, the agency considers the management of risks associated with an electronic interface incorporated into a medical device to be part of a comprehensive quality system under 21 C.F.R. Part 820. Manufacturers of interoperable medical devices should perform a risk analysis and conduct appropriate testing addressing the risks associated with interoperability, the anticipated users, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation. In particular, the Final Guidance identifies the following considerations that manufacturers should take into account and “appropriately tailor[]” to the device’s interface technology, intended use, and use environments

Read More: http://snip.ly/jeird#https://www.lexology.com/library/detail.aspx?g=54c0daa5-aed0-4976-995b-5e0204c336c4

Graham-Cassidy health care bill: What you need to know

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Sens. Lindsey Graham of South Carolina and Bill Cassidy of Louisiana have drafted the latest Republican attempt to repeal Obamacare. The bill would overhaul or eliminate major sections of the health care law, including its subsidized insurance coverage and Medicaid expansion. Instead, states would receive block grants, or a lump sum of money from the federal government, which they could use largely as they see fit.

How Graham-Cassidy would alter federal funding

Center on Budget and Policy Priorities analysis

The liberal-leaning think tank Center on Budget and Policy Priorities released estimates of how federal funding would change if the bill became law. In its analysis, California would be hardest hit, losing $27.8-billion in funding.

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  • $5,000
  • $8,500

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Graham-Cassidy-Heller-Johnson block grant model

Cassidy’s office released its own estimates. Massachusetts takes the hardest hit with a more than $5 billion loss in funding. Overall, Southern states that did not expand Medicaid are poised to receive more in federal funding.

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  • $-2,000
  • $0
  • $1,000
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  • $5,000
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  • $16,000

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The bill comes after three failed GOP repeal attempts in the Senate, and a proposal from Sen. Bernie Sanders to extend the reach of government subsidized health care to all Americans.

But Republicans are up against a tight deadline. Their budget reconciliation bill, which allows them to overhaul Obamacare with a simple majority, expires on Sept. 30. The deadline could work to Graham’s and Cassidy’s advantage, however, by spurring hesitant Republicans to seize what may be their last opportunity to deliver on their seven-year promise to repeal Obamacare.

 

Read More: http://snip.ly/v5ygq#http://www.politico.com/interactives/2017/graham-cassidy-health-care-bill-what-you-need-to-know/

FDA Breaks New Ground With First Approved Gene Therapy for Cancer

FDA Breaks New Ground With First Approved Gene Therapy for Cancer.jpg

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard.

“It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion.

June was referring to a revolutionary cancer therapy that he helped bring from lab bench to market. Co-developed with the drug giant Novartis, the therapy, CAR-T, genetically alters a patient’s own immune cells to target and destroy cancer cells.

Recently, in a historic decision, the FDA threw their support behind Kymriah (tisagenlecleucel), a “living drug” that is designed to treat blood and bone marrow cancer in children that, even with aggressive chemotherapy, is often lethal.

An entire process rather than a packaged pill, the therapy harvests a patient’s own immune cells—T cells that patrol and destroy abnormal cells—retrains them with extra bits of genetic code, and turns them into torpedoes aimed at cancerous cells once reintroduced into patients’ bodies.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Dr. Scott Gottlieb in a statement, adding that the therapy is “the first gene therapy available in the United States.”

Read More: http://snip.ly/bunjk#http://www.philly.com/philly/business/fda-advisors-give-a-thumbs-up-to-glaxosmithklines-shingles-vaccine-20170913.html