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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...
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    FDA Issues New Guidance on Osteoporosis Drug Development

    The US Food and Drug Administration (FDA) on Monday issued new draft guidance calling for drugmakers to conduct long-term nonclinical bone quality studies for osteoporosis treatments. According to FDA, such studies are necessary for osteoporosis drugs to determine whether the drugs result in poorer bone quality when taken for long periods of time. Additionally, FDA says these studies should be nonclinical, as "there are no validated and reliable methods for the noninvasi...
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    Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

    Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator. This week, the US Food and Drug Administration (FDA) released its warning letter for the company following an eight-day inspection in March 2015. The three major issues uncovered by FDA included the company’s failure to record or investigate quality-related customer compla...
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    European Regulatory Roundup: EMA Sets Up Antimicrobial Monitoring Program (14 April 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Sets out 5-Year Strategy for Antimicrobial Monitoring Program The European Medicines Agency (EMA) has published a draft strategy for the next five years of its program to monitor the use of antimicrobials. Over the period covered by the document, EMA plans to continue expanding the number of countries from which it gathers data with a view to ultimately covering ev...
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    FDA: Foreign Device Inspections on the Rise

    Newly released data shows the US Food and Drug Administration (FDA) conducted fewer medical device quality systems inspections in 2015 compared to recent years, while the number of foreign inspections increased to their highest number in a single year. In total, FDA conducted 2,104 inspections in 2015, down from 2,213 in 2014, approximately five to seven percent fewer than it conducted between 2011 and 2014. Quality Systems Inspections, 2008-2015 (Source: FDA) Nearl...
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    New ISO 13485: Device Companies Have Three Years to Transition

    The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements. Over the next three years, ISO 13485:2003 and ISO 13485:2016 ...
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    Updated: UK Company Banned From Shipping Medical Devices to US

    [ Editor's note from 2/25/16: This article has been updated with comment from Bedfont. ] The US Food and Drug Administration (FDA) has added UK-based Bedfont Scientific to its import alert list for medical device companies that have not met device quality system requirements. Bedfont is now banned from shipping its products to the US, which includes its breath test monitors, nitric oxide and carbon monoxide monitors, and medical pipeline testing equipment. “Foreign ...