• Love it or Hate it, the 21st Century Cures Act is a Big Step Forward

    21 December, 2016 Cindy Fazzi, Staff Writer

    The 21st Century Cures Act is a massive piece of legislation (996 pages) with an equally tremendous ambition. The life science industry heralded it as a victory, while critics expressed some concerns. Everyone agrees, however, that there’s a need to support medical innovation and advance regulatory compliance. The reform-minded law unites all sides to that extent.

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  • Top 8 Ways to Reach Regulatory Compliance

    8 December, 2016 MasterControl

    Many companies doing business in regulatory environments treat compliance like another obstacle to success. However, companies that live in regulatory environments have come to understand that compliance is actually a tool that can give them a competitive advantage. Statistics show that 72 percent of senior executives at regulated companies say that ensuring compliance with regulatory requirements is one of the most important challenges in their company.

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  • CLIA-phites vs. Quality-noids: Who Will Win the LDT Debate?

    6 December, 2016 Lisa Weeks

    The FDA’s proposed guidance for laboratory developed tests (LDTs) continues to create conflict between Quality-noids, those in favor of greater FDA oversight, and CLIA-phites, those who are not. Historically, the FDA has exerted little oversight of LDTs (e.g., no premarket review or quality system requirements) but that’s changing, largely because today’s LDTs are far more complex than the LDTs of the past. Both sides agree that more oversight is needed. Which federal agency should provide it, however, has sparked intense controversy.

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  • 4 Quality Management Tips We Can Get From Time Travel Movies

    20 October, 2016 David Jensen, Marketing Communications MasterControl

    Ever wish you could have a do-over? Wouldn’t it be nice to be able to go back in time to change or undo some event? Or what about going to a future time? Nothing illegal, maybe just to avoid the lines and hassle of getting a ticket to the next episode of Star Wars.

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  • How Well Do You Know Your FDA History?

    6 October, 2016 Lisa Weeks

    Fall is officially upon us, and we are settling into a new school year. As a child, I loved the beginning of school. It signified a fresh start

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  • Key Regulations & Initiatives that Modernized Compliance for Life Science Companies

    4 October, 2016 by Cindy Fazzi, Editor, MasterControl Insider

    Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.

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  • How to Use Postmarket Surveillance Data to Gain a Competitive Edge

    29 September, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.

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  • Is Compliance an Obstacle to Quality?

    15 September, 2016 Daniel Matlis, Founder and President, Axendi

    Can you distribute poor quality products while complying with regulatory requirements? Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

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  • UDI: When the Rule is Not Enough

    30 August, 2016 MasterControl

    With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.

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  • 10 Things I Wish I’d Known Before Writing my FDA Response Letter

    25 August, 2016 Lisa Weeks

    If you’ve ever received a 483 or warning letter, as I have, you know the chaos that can ensue. The clock is ticking; the FDA requires a response to most compliance notices within 15 business days!

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  • 3 Areas of Focus When Responding to FDA Inspection Findings

    28 July, 2016 David Butcher, Staff Writer

    When an FDA investigator issues a Form 483 after inspecting your facility, the cited observations should be addressed in writing to the FDA within 15 days, even if the initial response will be preliminary. To prepare an appropriate response to the audit findings and get on the necessary path to mitigate and resolve the identified issues, you’ll want to focus on at least three key areas, according to ARC Experts President and CEO Walt Murray.

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  • Failure of Management with Executive Responsibility

    19 July, 2016 Dr. Christopher Joseph Devine, President, Devine Guidance International Inc

    For the second time in three weeks, Dr. D was able to quickly locate another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing. Now granted, from time-to-time it becomes a challenging task for the management representative to circle the wagons and corral all of the management-types into the executive conference room for a meeting focused on the performance of the quality management system (QMS). However, every Chief Jailable Officer (CJO) clearly understands the ramifications associated with not complying with the FDA’s sacred text, the quality system regulation (QSR). In fact, not being able to share at least documented evidence that a management review has occurred (agenda and sign-in sheet) is just not excusable. Heck, the agency even gives a ton of wiggle room with the “planned intervals” requirement, so holding at least one review annually should be a piece of cake. Right? Well, based on the performance of the device establishment targeted in this week’s guidance, the answer is a big “evidently not!” As many of the doctor’s friends and readers know, Dr. D is somewhat of a wisenheimer (look-it-up). However, when it comes entertaining the FDA during one of their friendly visits for a cup of coffee and an inspection, it is always Game On! Enjoy.

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  • The First Step To Navigating Your Combination Product's Regulatory Pathway: PMOA

    23 June, 2016 Winston Brown, VP of Global Quality & Regulatory Affairs Phillips-Medisize

    The drug-device combination product market is growing at a rapid pace. By 2019, it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012.(1) This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained. To avoid unnecessary delays and gain speed to market through ‘right the first time’ regulatory submissions for a combination product, sponsor companies must understand the various pathways for which a combination product can travel. In addition, companies must also understand their own products enough to be able to discern what specific regulatory path it would follow. This not only preserves the relationship between sponsors and regulators, but it also ensures safe and effective medical treatments reach patients in a timely manner.

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  • Need Help Navigating UDI? FDA Can Help

    10 May, 2016 Compiled from MedTech Intelligence and FDA reports

    Although the unique device identification (UDI) rule was finalized in September 2013, the compliance rollout period will last several years (based on device classification). To help companies as the rule is phased in, FDA has posted five new education modules. You can find these on the CDRH Learn site.

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  • Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products

    28 April, 2016 Jeffrey K. Shapiro & Charlene Cho Hyman; Phelps & McNamara, P.C.

    In the emerging world of regenerative medicine, there is a stark dichotomy in the level of regulation applied to products derived from human cells and tissues, or what FDA calls “human cells, tissue or cellular and tissue‑based products” (HCT/Ps).

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  • Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) Plan

    19 April, 2016 Mark Schwartz Of Counsel, Hyman, Phelps & McNamara P.C.

    There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.

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  • The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

    17 March, 2016 Dr. Candida Fratazzi, M.D., Founder/CEOBBCR Consulting, (Boston Biotech Clinical Research)

    The average cost of developing a new drug is notoriously high. In a study conducted through the Tufts Center for the Study of Drug Development in 2014, Dr. Henry G. Grabowski and Dr. Ronald W. Hansen concluded, “The estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is 2,558 billion.” The story does not end here. For the past 20 years, the cost of new drug development has risen at a rate that was 7.4% higher than inflation, and clinical trials bear responsibility for most of that increase. However, the increasing cost of biomedical research is not reflected in an increase in the success rate of clinical development. Instead, it presents a major hindrance to innovation in the biotech industry, while the public must bear the brunt of the problems, absorbing the steep rise in the prices of drugs and medical devices. In order to boost the efficiency of the biotechnology industry, remove the burden of expensive drugs, and create life science products in line with the future of healthcare, we should be asking how best to modify the development process to make it cost-effective.

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  • The #1 Cause of Medical Device Recalls—and How to Avoid It

    8 March, 2016 Lisa Weeks, MasterControl Communications

    Would it surprise you to learn that the most common cause of medical device recall, according to the FDA, is software design failure? It shouldn’t. These days, it’s hard to find a device that doesn’t rely on the use of sophisticated software to operate. What’s more, a defective software component is often harder to detect than, let’s say, a defective electrical component. It really is the perfect recipe for design disaster, but it doesn’t have to be—if you know how to use risk.

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  • The Past, Present and Future of CAPA

    23 February, 2016 James Jardine, Marketing Communications Specialist, MasterControl

    Every day, companies in regulatory environments are amplifying their efforts to avoid the seemingly inescapable consequence of an egregiously oversaturated corrective and preventive action program, or, as it’s commonly come to be known, “Death by CAPA”. A recent MedTech Intelligence article by CAPA guru Ken Peterson speaks to the evolution of CAPA, discusses the refinement of effective CAPA programs and hints at what is on the CAPA horizon in the future.

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  • FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

    9 February, 2016 Jason C. Gavejian, CIPP, Principal, Jackson Lewis P.C.

    Last week (January 22, 2016), the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have entered the market, is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices in the face of potential cyber threats.

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