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    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    • 22 November 2016
    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
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    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
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    US, EU Look to Mutually Recognize GMP Inspections by January 2017

    The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP). Progress on mutually recognizing GMP inspection has been ongoing since June , particularly as the US Food and Drug Administration (FDA) has observed at least eight audits since 2014 and as six additional aud...
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    New Report Investigates Use of Analytics to Measure Medical Device Quality

    The Case for Quality, a public-private partnership between the US Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC), has released a new report on the feasibility and effectiveness of using analytics to measure medical device quality in healthcare decision-making. In order to measure these factors, a Case for Quality working group ran a pilot focusing on knee and defibrillator implants at seven hospitals to determine whether data, both...
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    FDA to Hold One Advisory Committee for Each Initial Biosimilar

    The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each of the first new biosimilars for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application. Marjorie Shapiro, chief of the laboratory of molecular and developmental immunology at FDA, told attendees at the annual PDA/FDA conference in Washington, DC, that the first biosimi...
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    FDA to Revise Draft Guidance on Quality Metrics Data

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday offered a couple of revisions to its list of guidance documents for 2016. Most notably, a revision to the agency’s draft guidance on quality metrics is expected later this year. The revision on the quality metrics data draft comes as FDA has received 79 comments on the first draft released in July 2015, and as many at the PDA/FDA Joint Regulatory Conference on Monday i...
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    FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

    The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies. The 142-page proposed rule outlines what’s referred to as a “GLP Quality System,” which will involve additional management responsibilities and standard operating procedures (SOPs), as well as a more nuanced approach for multi-site ...
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    FDA Warns 14 International Medical Device Companies

    The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines. By far the most common issues cited by FDA were: Number of Citations Issue 11 Failure to establish and maintain adequate procedures for imple...
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    FDA to Drug Compounders: Inspection Changes Coming in August

    The US Food and Drug Administration (FDA) on Tuesday announced major changes with respect to inspections of drug compounders as infections linked to poor quality drugs continue to crop up. For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators wi...
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    FDA Warns Zimmer Over Quality System Issues at Montreal Plant

    The US Food and Drug Administration (FDA) has issued medical device maker Zimmer Biomet a warning letter over nine quality system issues uncovered at its facility in Montreal. The warning comes as a result of a four-day inspection of the facility that resulted in an FDA Form 483 last January, during which, FDA says its investigators found issues with the company's procedures for implementing corrective and preventative actions, medical device reporting (MDR), purchasing ...
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    Quality Metrics: FDA Outlines What Data to Submit

    The technical reference document released Friday from the US Food and Drug Administration (FDA) provides recommendations to pharmaceutical companies on the submission of records and other information to support FDA’s calculation of quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment. The 10-page guide follows the creation of an Office of Pharmaceutical Quality , the release of draft guidance for industry, known...
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    FDA Issues Draft Guidance on Critical Quality Attributes for Chewable Tablets

    The US Food and Drug Administration (FDA) on Thursday issued new draft guidance covering the quality attributes drugmakers should consider when developing chewable tablets. The guidance also includes recommendations for what information drugmakers should include when submitting developmental, manufacturing and labeling information to FDA. FDA says the new guidance is needed, as "numerous approved drug product applications for chewable tablets revealed that in certain ca...