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Showing items tagged as U.S. Food and Drug Administration

  • Software as a Medical Device: What Does It Mean and Why Should I Care?

    4 January, 2018 by Mike Rigert, Staff Writer, MasterControl

    A little over a year ago, the U.S. Federal Drug Administration (FDA) released its draft guidance (1) regarding a newer, skyrocketing segment of the medical device industry—that of Software as a Medical Device (SaMD). The guidance means to address the emergence of thousands of stand-alone, health-oriented software apps that fall into a gray area in terms of regulation. Obviously, SaMDs aren’t traditional medical devices, but neither are they Pokémon Go.

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  • 5 Most Common Pharma Form 483 Quagmires & How to Avoid Them

    26 December, 2017 by James Jardine, MasterControl Communications

    See the most common reasons the FDA cited pharmaceutical companies with Form 483 Inspectional Observations last year and examine potential remedies that can help prevent future warnings.

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  • Canada’s Evolving Regulatory Landscape

    26 September, 2017 Raleigh Malik, PhD, Sr. Scientist; DIA

    Canada’s sesquicentennial marks a period of advancement and newfound transparency, where the past has set the stage for innovators to generate novel, yet safe and effective, health care products for Canadians. From the discovery of insulin at the University of Toronto in 1921 to the development of the first HIV preventative vaccine in 2013 (which is currently undergoing Phase II trials), Canada has a rich history of drug innovation. However, with health care product innovation comes government oversight and regulations required to ensure safe and effective treatments for the public.

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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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  • The FDA Just Completed Its Inspection...Now What?

    12 May, 2016 David R. Butcher, Marketing Communications, MasterControl

    Even after an FDA investigator has completed an inspection at your facility, there’s still plenty of work that remains. At the conclusion of an audit, the inspector will hold an exit interview to discuss observations and present significant findings on a Form 483. What do you do next?

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  • The FDA Just Called! Are You Ready for an Inspection?

    27 January, 2016 David R. Butcher, Marketing Communications, MasterControl

    If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you go into panic mode or would you go on with your day, business as usual? For many, an FDA inspection can be a scary prospect. It can be extremely difficult, and failing it can have significant consequences. With proper preparation, however, the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

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  • FSMA: Get Inspection-Ready with These Best Practices

    20 October, 2015 Melanie J. Neumann, J.D., M.S. Executive Vice President The Acheson Group

    Although FDA immediately gained increased authority for records access upon the signing of the Food Safety Modernization Act (FSMA) in January 2011, some companies haven’t gotten the memo yet.

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  • OMG! The FDA Is Keeping Up With Kim Kardashian, Too

    28 August, 2015 Alex Butler, Product Manager, Life Science Applications (LS APPs), MasterControl

    Love her or hate her, reality-star Kim Kardashian knows how to get our attention. Whether she’s trying to break the Internet with risqué photos or agonizing over which Rolex to wear, people are watching. Kardashian boasts more than 34 million Twitter followers; 26, 074, 878 likes on her Facebook fan page; and 42 million Instagram followers. Forty-two million! That’s how many people may have seen her infamous July 19 Instagram post praising the morning sickness drug Diclegis® that landed her and drug maker Duchesnay in hot water with the FDA. “Kim Kardashian’s greed finally got the better of her,” the author of one op-ed piece for the popular U.K. tabloid the Mirror gleefully exclaimed.1 I’m not so sure. Perhaps Kim Kardashian is smarter than we think.

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  • FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users

    11 June, 2015 Stacie L. Ropka and Chad A. Landmon Axinn, Veltrop & Harkrider LLP

    What does the Food and Drug Administration (FDA) consider to be “minimal manipulation” and how are human cells, tissues and tissue-based products (HCT/Ps) made from adipose tissue regulated by FDA? These questions were addressed in two draft guidances issued by FDA in late December of 2014. The first, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations (1), focuses on how adipose tissue is defined and thus how adipose-based HCT/Ps are regulated by FDA. The second, Minimal Manipulation of Human Cells, Tissues and Tissue-Based Products (2), focuses on the types of cell and tissue processing that would be considered more than minimal manipulation, resulting in the regulation of the cell or tissue-based product as a drug, biologic or medical device. Although they are not yet final, these guidances shed light on FDA’s current thinking and may signal that FDA will make it more difficult for products to be regulated solely under Section 361. Not only will such a position by FDA impact development of new HCT/Ps, but it could threaten the regulation status of currently marketed HCT/Ps.

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  • Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

    18 February, 2015 Suzanne M. O'Shea, Counsel, Faegre Baker Daniels LLP

    Two years ago, in January 2013, FDA published the final regulations on Good Manufacturing Practices for Combination Products.[1] These regulations are built on the concept that the constituent parts of a combination product retain their regulatory identity as a drug, device, or biological product, even after they are physically, chemically, or otherwise combined into a single-entity combination product (i.e., prefilled injector or drug eluting stent) or co-packaged together.[2] Therefore, all the good manufacturing requirements associated with each constituent part must be complied with in the manufacture of single-entity and co-packaged combination products.

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