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PATHWISE INDUSTRY NEWS

Read important industry news with the latest articles on life sciences, manufacturing, and regulatory issues. 

JUNE 2020 INDUSTRY NEWS

 

Children with ADHD can now be prescribed a video game, FDA says

“The first video game-based treatment for attention deficit hyperactivity disorder (ADHD) has been approved by the US Food and Drug Administration (FDA).The video game, called EndeavorRx and approved on Monday, will be prescription only and aimed at children between the ages of eight and 12 with certain types of ADHD. It will be used alongside other treatments, such as clinician-directed therapy, medication and educational programs. ADHD is a common neurodevelopmental disorder which is usually first diagnosed in children and can last into adulthood.

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Human Factors Engineering (HFE) During the COVID-19 Pandemic

There has been a lot of speculation, and also pessimism to some extent, regarding the implementation of Human Factors Engineering (HFE) into the design of medical devices and combination products in the current COVID-19 pandemic. This is not surprising given the challenges the situation has posed—travel restrictions, social distancing, government and local regulations and guidelines, and above all, the risk of contracting and transmitting the disease for which there is currently no definitive treatment or vaccine.”

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How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis

“The COVID-19 pandemic has disrupted clinical trials globally and has resulted in a 65% worldwide decrease in new patient enrollment year-over-year during March 2020. As a result, regulators across the globe have issued new guidances to support the industry in their hour of need. The US Food and Drug Administration (FDA) has launched a special emergency program for possible therapies for COVID-19 – the Coronavirus Treatment Acceleration Program (CTAP), which combines elements of multiple existing review pathways. “

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FDA

Hahn: Permanently adopting R&D-accelerating COVID-19 measures is a top FDA priority

“FDA Commissioner Stephen Hahn, M.D., has vowed to permanently adopt COVID-19-driven changes that make reviews and authorizations faster. Hahn made the commitment in a speech that called on the FDA to learn from the crisis to enact lasting policies that accelerate drug development. Fresh from a 14-day quarantine necessitated by contact with someone infected with COVID-19, Hahn set out how the FDA responded to the crisis and how it will shape the future of the agency. While acknowledging that the FDA’s response to the pandemic encountered some “hiccups,” Hahn sees positives that support the accelerated transformation of the agency under his leadership.

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MAY 2020 INDUSTRY NEWS

 

FDAFDA plans phased approach to restarting surveillance inspections

“After halting most foreign and domestic inspections in March due to the coronavirus disease (COVID-19) outbreak, the US Food and Drug Administration on Monday said it is working with the Centers for Disease Control and Prevention (CDC) on a phased plan for resuming on-site surveillance inspections. In March, FDA said it would halt foreign inspections and domestic routine surveillance inspections and would only conduct “mission-critical” foreign or domestic for-cause  inspections. In lieu of on-site inspections, the agency said it would resort to alternative means of oversight, such as evaluating records from facilities. “

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Eudamed update: Phased implementation planned for European medical device, IVD database

The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official Eudamed date of application in May 2022. In this way it becomes possible for economic operators to start using Eudamed before they are legally required to do so. This will help companies to prepare and will also help the authorities to smooth out unforeseen issues before the date of application.”

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In the Race Towards a Vaccine, Manufacturing and QC Must Keep Pace

“The COVID-19 pandemic is “an unprecedented crisis, and we’ve never seen anything like it,” Pat Shafer, managing director in Grant Thornton‘s healthcare and life sciences industry business, told MD+DI recently. Judging from the amount of stories MD+DI has published alone in the last several weeks on the rapid responses from many medical device and diagnostics companies as well as industry suppliers, manufacturers are working quickly toward several potential solutions. The medical device industry has been very agile in responding to the pandemic, Shafer said. “Most manufacturing has not had any production stoppages, and factories are still open, and many have sufficient supplies on hand.”

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Coronavirus vaccine developers plan to enroll tens of thousands in late-stage tests

“Coronavirus vaccine developers, working against the clock to quickly prove their experimental candidates, are preparing for late-stage clinical trials that would enroll tens of thousands of people in the U.S., Europe and, potentially, other regions as the pandemic’s heaviest impact begins to shift to the Southern Hemisphere. So far, early safety studies of coronavirus vaccines have involved several dozens to hundreds of healthy volunteers. But establishing the safety and effectiveness of a treatment that could potentially be given to tens of millions of people globally will require massive trials spanning many countries.”

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APRIL 2020 INDUSTRY NEWS

Medtech Perseveres During COVID-19

“The COVID-19 pandemic is “an unprecedented crisis, and we’ve never seen anything like it,” Pat Shafer, managing director in Grant Thornton‘s healthcare and life sciences industry business, told MD+DI recently. Judging from the amount of stories MD+DI has published alone in the last several weeks on the rapid responses from many medical device and diagnostics companies as well as industry suppliers, manufacturers are working quickly toward several potential solutions. The medical device industry has been very agile in responding to the pandemic, Shafer said. “Most manufacturing has not had any production stoppages, and factories are still open, and many have sufficient supplies on hand.”

READ THE FULL ARTICLE HERE

Amazon is building it’s own Covid-19 Testing Lab for Employees

“As pressure mounts on Amazon to keep its warehouses running smoothly and at maximum capacity while also addressing safety concerns from workers, the e-commerce giant has hatched plans to build its own Covid-19 testing facilities. Amazon announced this past week it has started assembling equipment for its first testing lab. The company said it hopes developing “incremental” testing capabilities will help it monitor the health of its hundreds of thousands of workers, including those displaying no symptoms of the virus…Amazon has pulled research scientists, program managers, and procurement specialists onto the testing project from their normal day jobs. 

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Covid-19 Could Change Pharmaceutical Supply Chain Forever

“With a vast number of direct-to-user/patient shipments happening today in healthcare, especially as the nation battles the contagious coronavirus by complying with stay-at-home edicts, we are seeing unprecedented activity in last-mile deliveries. What challenges do pharmaceutical companies and pharmacies need to solve? How will this experience affect the future of pharmaceutical logistics? Valerie Metzker, head of business development for Roadie, offers several ideas in this X-minute interview.”

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European Leaders, WHO team up on $8B pandemic vaccine response

“The leaders of Germany and France and a host of other EU countries and groups have come together with the World Health Organization (WHO) for an $8 billion push for a new vaccine against COVID-19. This comes as the pandemic hit 3 million recorded cases this week, with around 206,000 official deaths, though both cases and mortality are suspected to be much higher given the methodology many are using to tot up the grim statistics. As the world continues to battle the virus, French President Emmanuel Macron and German Chancellor Angela Merkel have spearheaded a European drive to work with the WHO for a vaccine via an $8 billion project. A conference to discuss project’s funding is to be held May 4, with more details to be revealed.”

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Optimizing remote Internal Quality Audits

“This article provides tips and techniques for effective, risk-based remote internal quality auditing methods in a good manufacturing process (GMP) quality management system. The author covers the circumstance in which a “virtual” audit may be necessary or desirable as opposed to an on-site audit and discusses potential challenges when auditing off-site and how to overcome them. She emphasizes good communication skills, discusses the characteristics of various internal audit methods, how to prepare for remote internal audits and concludes remote internal auditing can support ongoing operations and improve audit effectiveness during unusual times or in the normal course of business.”

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MARCH 2020 INDUSTRY NEWS

Pharmaceutical

GOP lawmaker introduces bill to end dependency on China’s pharmaceutical manufacturing

“In the wake of the coronavirus pandemic and supply chain disruptions, one Republican lawmaker is seeking to decrease America’s dependence on China. Appearing on “Fox and Friends” Sunday, Sen. Marsha Blackburn (R-Tenn.) explained that she has introduced legislation to increase America’s pharmaceutical production to decrease dependency on China. “It is the SAM-C Bill, Securing America’s Medicine Cabinet,” Blackburn said. “Many of the pharmaceuticals that are necessary for creating some of these viruses — and certainly the coronavirus family is one of those — they’re made only in China. We are depended upon them for these. They’re called APIs: active pharmaceutical ingredients,” she continued. “My legislation would incentivize bringing that production back on U.S. shores.”

READ THE FULL ARTICLE HERE

FDA

FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

“Today, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing. “The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services Secretary Alex Azar. “Today’s actions are another step by the FDA and HHS to eliminate every possible barrier to the all-of-America approach that President Trump has called for. With this boost from the FDA, medical device makers can more easily make changes to existing products, such as changes to suppliers or materials, to help address current manufacturing limitations or supply shortages. Other manufacturers, such as auto makers, can more easily repurpose production lines to help increase supply. Hospitals and other health care providers can repurpose machines they have now to serve as ventilators. HHS and FDA’s message is clear: If you want to help expand production of ventilators to save American lives in this pandemic, we are going to work with you to sweep every possible barrier out of your way.”

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FDA now allows treatment of life-threatening COVID-19 cases using blood from patients who have recovered

“The U.S. Food and Drug Administration (FDA) has updated its rules around use of experimental treatments for the ongoing COVID-19 pandemic to include use of “convalescent plasma,” in cases where the patient’s life is seriously or immediately threatened. This isn’t an approval of the procedure as a certified treatment, but rather an emergency clearance that applies only on a case-by-case basis, and only in extreme cases, as a means of helping further research being done into the possible efficacy of plasma collected from patients who have already contracted, and subsequently recovered from, a case of COVID-19. Plasma is a component of human blood — specifically the liquid part — which contains, among other things, antibodies that contribute to a body’s immune response. Use of plasma, through direct transfusion into a patient, like every other proposed treatment for COVID-19 (and the SARS-CoV-2 virus that causes it), has not undergone the clinical studies needed to show that it’s actually safe and effective in combating the disease.”

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