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PATHWISE INDUSTRY NEWS

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

DECEMBER 2019 INDUSTRY NEWS

The IMDRF Cybersecurity Guidance: A Comprehensive Analysis

“Currently, cybersecurity guidelines for medical devices vary from country to country. In the United States, the U.S. Food and Drug Administration (FDA) has released two guidance documents aimed primarily at medical device manufacturers. Content for Premarket Submissions for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices — issued in 2014 (updated in 2018) and 2016, respectively — provide important information about what the FDA expects relevant to cybersecurity in premarket submissions and in postmarket management plans. These guidance documents have become the basis for regulatory guidance in several other countries. However, many countries have developed different guidelines or have not issued any guidance at all, creating significant confusion in the marketplace.

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FDA

Senate confirms Dr. Stephen Hahn as FDA commissioner

“The US Senate on Thursday confirmed Dr. Stephen Hahn to be the next commissioner of the US Food and Drug Administration. The Senate vote was 72 to 18. Hahn, 59, is a well-known radiation oncology expert and is the current chief medical executive of The University of Texas MD Anderson Cancer Center in Houston, where has been a professor of radiation oncology since January 2015. “Dr. Hahn can now get to work approving new life-saving drugs and devices, regulating tobacco and e-cigarettes, addressing the opioid crisis, ensuring pain patients can receive the medications they need and protecting our nation’s food supply,” Republican Sen. Lamar Alexander wrote in a Twitter post following the confirmation.”

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Medical Device

Medical Device Tax Is History After Trump Signs Repeal

The medical device industry hailed President Trump’s signing into law a bipartisan federal spending package that brings in an end to a tax the medical technology industry has been fighting against for the last decade. The 2.3% tax on medical device sales that is part of the Affordable Care Act has already been on temporary hiatus since the beginning of 2016, but was scheduled to return at the end of this year if Congress didn’t eliminate the tax or put it on hiatus once again. Medical device makers feared a major hit to their bottom lines, research budgets and jobs if Congress didn’t end or at least shelve the tax before the end of the year. A report released earlier this month from the Tax Foundation shows a return of the medical device tax would “would result in a decline of 21,390 full-time equivalent jobs and a reduction in GDP of $1.7 billion.”

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NOVEMBER 2019 INDUSTRY NEWS

FDA

Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff: Draft Guidance

“Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft document. Submit electronic comments to https://www.regulations.gov.  This document, 1 55 Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA 56 Staff, sets forth risk-based principles by which the Food and Drug Administration (FDA or Agency) 57 conducts ongoing postmarketing safety surveillance for human drug and biological products (biologics).”

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Compliance Training

ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

“A recently released survey from the International Council on Harmonisation (ICH) shows pharmaceutical regulators and companies around the world are adopting and adhering to the council’s guidelines related to quality, safety and efficacy.
The survey of 32 pharmaceutical companies provided responses on 15 regulatory authorities, which included the founding ICH members: the European Medicines Agency, the US Food and Drug Administration, Japan’s MHLW/PMDA, Health Canada and Swissmedic, as well as other newcomers from Brazil, China, Singapore and South Korea, and observers from Malaysia, Russia, South Africa and Turkey.”

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How software may be classified under medical device regulation guidance

“The new regulatory landscape on software medical devices that will apply under the new Regulations (Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/756 (In Vitro Diagnostic Regulation (IVDR)) as of 26 May 2020 and 26 May 2022 respectively, has been somewhat clarified by new guidance published by the European Commission’s Medical Devices Coordination Group (MDCG). Given that the Guidance has been the result of considerable work/ deliberations by the MDCG, due to the particularities of and fast pace of innovation in software as a medical device, one would expect more topics to have been addressed and perhaps in more depth. Still, this Guidance provides the first valuable insight into how software will be classified under the new Regulations, while more specific examples will continue to be included in the Borderline manual guidance.”

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Drugs

Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings

“The latest regulatory agenda for the US Food and Drug Administration (FDA) was released on Wednesday, announcing the delays of several proposed rulemakings, and one new but expected addition on the importation of prescription drugs.
On importation, the proposed rule, which has been under review at the Office of Management and Budget since the beginning of November and is expected to be released by January, would allow pharmacists and wholesalers to import prescription drugs from Canada if the imports pose no additional risks and will save money. The proposed rule is expected to have several key limitations (i.e. only facilities that also manufacture API for the FDA-approved version would be allowed) and exclusions (no costly biologics, drugs with a REMS or infused or injected drugs) that may raise questions about what drugs could be imported and how much could be saved.”

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OCTOBER 2019 INDUSTRY NEWS

FDA

Understanding the FDA Form 483: A Q&A with NSF’s Maxine Fritz

The FDA Form 483 is not an extensive list of all potential problems, but only those that inspectors can clearly identify as potential violations to FDA regulations. A detailed establishment inspection report (EIR) is written by the FDA inspector/inspection team that further outlines details of the company, its facilities, processes, quality systems, products, refusals, inspectional observations and discussion with management. The company should address these inspectional observations in a written response to the FDA following the inspection. The written response to the FDA 483 should outline the holistic improvements and corrective actions to be taken to remedy the observation and the timeline that it will take to complete them.

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MDR/IVDR Guidance: MDCG Explains What’s Coming

“The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE).
The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 2020, although for more than 20 guidance documents, the timing is to be decided.”

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cGMP

FDA is smashing the status quo for regulatory science

“Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality,” may have sounded like another bland and boring exercise in regulatory rhetoric. But it actually signals a revolutionary shift in regulatory velocity. Changes in the FDA’s Office of New Drugs (OND) will create enhanced review zones that cross disease areas and divisions to maximize access to more focused and innovative areas of regulatory expertise. These changes will, among other things, increase the number of OND offices overseeing product reviews from six to eight and increase the number of specific clinical review divisions from 19 to 27. The rationale is to make the FDA more efficient and help it better understand the diseases that are the aim of treatment by the drugs being evaluated for approval.

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FDA Toughens Enforcement of Homeopathic Products

“FDA recently announced that it was taking two significant actions with respect to products marketed as homeopathic drugs, suggesting that increased enforcement related to these products is imminent. Homeopathy is a form of alternative medicine that is based on the idea that illnesses and their symptoms can be treated by small doses of ingredients that produce similar symptoms in healthy people.”

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SEPTEMBER 2019 INDUSTRY NEWS

How Apple, Fitbit, Samsung and more are helping to modernize the FDA

“The healthcare industry is notorious for being slow to implement the type of technology that has revolutionized other industries such as retail, media and manufacturing. And there’s one big reason why: Regulation.  But that’s changing. Over the past decade, the US Food and Drug Administration has recognized that the systems the agency has in place to review and approve moderate- to high-risk hardware-based medical devices (such as implantable pacemakers and breast implants) aren’t appropriate for the low-risk software-based medical technologies flooding the market place today. (These include apps that help detect skin cancer and smartwatches that can take your blood pressure.) “

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Safer Technologies Program for Medical Devices

“The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products1 that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program; for example, this may include devices treating or diagnosing non-life-threatening or reasonably reversible conditions. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classificationrequest (“De Novo request”), or premarket notification (510(k)). “

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No-deal Brexit and the medical device industry: what to expect

“It’s safe to say very few commentators, within or outside the medical device industry, are actively championing the prospect of a no-deal Brexit. The EU is the UK’s biggest trading partner for health technologies, with around £2bn worth of goods exported into Europe each year and £3.3bn in European medical products imported into the country. Considering the sheer scale of the sector, talk of border delays, technical hold-ups and stockpiling bodybags hasn’t exactly painted a hopeful picture of the situation, and the overarching impact of no-deal on medical devices could be huge.”

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cGMP

FDA explains plans for new pharmaceutical quality assessment system

“As part of its work to improve and modernize the quality assessment of drug applications, the FDA is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from the FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics. The authors describe KASA as a new system that captures and manages information in a structured format about the inherent risk and control approaches for product design, manufacturing and facilities.”

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AUGUST 2019 INDUSTRY NEWS

Medical Device

Boosting Medical Device Quality and Profitability via a Common Product Model

“Medical device manufacturers face hurdles taller than ever in getting high-quality products to market faster, cost-effectively. Hindering their efforts are not just external factors but also internal processes for designing and producing those products. That is why it’s time for medical device companies to adopt a design-to-manufacturing environment where designers, engineering, and production teams are synchronized on a common product model. This approach improves both product quality and profitability by reducing errors in production while increasing yield rates.”

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Industry backs Australia’s device identifier plan with caveats

When Australia’s Therapeutic Goods Administration ran the UDI consultation at the start of the year, it sought to gather views on the merits of introducing a system it thinks it will improve outcomes, including patient safety. The response to the consultation suggests the creation of a UDI system will go ahead. TGA found a “strong consensus across all stakeholder groups for the need to introduce the UDI system,” leading it to move forward with the development of legislation that will facilitate the work.

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Compliance Training

Which GMPs for the cannabis industry? Pharmaceutical, food, or dietary supplement

“As with all molecular entities—whether chemical, botanical, or food-derived—FDA has one main focus: to ensure the safety, identity, purity and quality, and intended use of the ingredient is suitable for human and animal use. The use, dependent on the label claim and other regulatory considerations, can be categorized as a cosmetic, drug, food ingredient, or dietary supplement. Following a standard for manufacturing is the end result of implementing regulatory and quality considerations.​”

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Changing  3 More Years: US calls for delay on the implementation of EUMDR/IVDR

The US highlighted what it believes to be the main issues surrounding the implementation of these regulations in a statement to the World Trade Organisation committee on technical barriers to trade: “Our industry is worried about their continued access to the EU’s USD 125 billion medical device market, 20 billion USD of which is supplied by US products. To date the European Commission (EC) has designated two Notified Bodies (NBs) – BSI UK and TUV SUD against MDR and none against IVDR. Additionally, only one regulation that has been put forward has been adopted so far; the EC issued the draft implementing regulation on the common specifications for the reprocessing of single-use medical devices in accordance with the MDR last month.

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MDSAP – History and Advantages

“A few years ago, the U.S. Food and Drug Administration (FDA) realized there was no hope of achieving the legislated mandate of inspecting every Class II and Class III medical device manufacturer every two years. Congress would not provide the finances to hire enough investigators to perform those routine quality system inspections, in addition to required premarket approval (PMA) inspections, clinical trial (BIMO) inspections, and any recall or other enforcement inspections.

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