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  • Regulatory NewsRegulatory News

    3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks

    As part of a project on emerging technologies, six regulators involved in the International Coalition of Medicines Regulatory Authorities (ICMRA) recently published a case study delving into the challenges of regulating 3D bio-printed products. In this hypothetical case, the regulators evaluated 3D bio-printed knee meniscus tissue and discussed how they would tackle similar products. The case study was conducted by Australia’s Therapeutic Goods Administration (TGA), Bra...
  • Regulatory NewsRegulatory News

    3D Printing: FDA Finalizes Guidance for Medical Devices

    The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing. The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft. FDA Commissioner Scott Gottlieb said Monday that the guidance "will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submis...
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    FDA to Issue More Guidance on 3D Printing

    As manufacturers use 3D printing to create devices matched to a patient’s anatomy and devices with complex internal structures, the US Food and Drug Administration (FDA) is working with universities, researchers and industry to further understand these products and issue more guidance. According to a video ( The 3Rs of 3D printing: FDA’s Role ) from FDA posted Wednesday, Lt. James Coburn, senior research engineer at FDA, says, “We’re a long way off from having a 3D print...
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    European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EUnetHTA Nears Start of Third Phase of HTA Cooperation Agenda The European network for Health Technology Assessment (EUnetHTA) is on the cusp of entering the third phase of its agenda. Members of the European Commission and the Dutch National Health Care Institute began a 30-day countdown to the official start of the program by signing a grant agreement.  When the of...
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    3D Medical Device Printing: Industry Seeks More Clarity From FDA

    Medical device manufacturers are looking to coax the US Food and Drug Administration (FDA) into providing more clarity on its guidance on 3D printing, according to comments released Friday. As 3D printing, also known as additive manufacturing (AM), continues to make headway in the market (FDA has approved 85 3D printed devices as of December 2015), and more technological advances encourage more investment, device manufacturers are calling on FDA to expand its thoughts on...
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    FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices

    The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing. In March, FDA approved the first-ever 3D printed drug, Aprecia's epilepsy drug SPRITAM , which relies on 3D printing technology to rapidly disintegrate in a patient's mouth, making it easier to swallow. For biologics, researchers are looking into 3D printing as a means of manuf...
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    FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics

    The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates. The ELP Program FDA's Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort to reform the Center for Devices and Radiological Health (CDRH) in light of criticism that the center was too out of touch with challenges faced by device manu...
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    FDA Plans Meeting to Explore Regulation, Medical Uses of 3D Printing Technology

    The US Food and Drug Administration (FDA) plans to soon hold a meeting to discuss the future of regulating medical products made using 3D printing techniques, it has announced. Background 3D printing is a manufacturing process which layers printed materials on top of one another, creating three-dimensional parts (as opposed to injection molding or routing materials). The manufacturing method has recently come into vogue with hobbyists, who have been driven by several ...