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    CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway

    Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office." The so-called "Total Product Life Cycle 'Super' Office" will integrate premarket, postmarket surveillance and quality-compliance functions, Shuren said, noting it will be "a big deal." The o...
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    FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors

    The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May. According to FDA, the firm's management admitted to falsifying analytical test results used to release a lot of its products to the US. In another instance, FDA says the firm reported that a batch of one of its products was within specification ...
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    FDA Plans to Finalize 510(k) Change Guidances Ahead of November Deadline

    An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidances detailing when a new 510(k) is required for changes to medical devices and their software before the 8 November 2017 deadline set by the 21st Century Cures Act . In August 2016, FDA released the two draft guidances , five years after the agency's first attempt to replace its 1997 guidance on the topic. But, FDA withdrew the 2011 draft guidance after ...
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    Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

    The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found a higher association with these expedited pathways and the likelihood of safety-related labeling changes than with non-expedited pathways. In their analysis of 15 years of data, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Program on Regulation, Therapeutics, And Law...
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    EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form

    The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). The update, drafted in July 2015 , comes as there has been an increasing trend toward the outsourcing of manufacturing and more complex supply chains. The guideline "does not introduce new requirements" on authorized drugs, though t...
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    Proposed and Final FDA Rules: What’s Left in 2017

    The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings. Proposed Rulemakings Among the proposals coming are rulemakings dedicated to pediatric study plan requirements , internal decision making and supervisory review at FDA’s Center for Devices and Radiological Health, the withdrawal of a regulation that a...
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    FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics

    As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report. "Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, o...
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    Australia Proposes New Risk-Based Approach to Medicine Variations

    Australia's Therapeutic Goods Administration (TGA) on Thursday released guidance on a plan to allow companies to make "very low risk" changes to registered medicines after submitting them to TGA and receiving an automated acknowledgement. "These requests are known as 'notifications' but still require an application to the TGA," the regulator explained. "These lowest risk variations do not require evaluation but legally must still be approved by the TGA before imple...
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    FDA Warns Lonza’s Class II Device Manufacturing Site

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD. The four observations from the inspection conducted from 18 January 2017 through 6 February 2017 deal with validation failures, the site’s failure to develop, conduct, control and monitor production processes, corrective and preventive action (CAPA) failures and a failure to adequately establis...
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    FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds

    For drugs approved by the US Food and Drug Administration (FDA) based on limited evidence, a recent study published in the British Medical Journal found “noticeable variability” in the degree to which novel drugs were studied in the postmarket period. The authors, including Yale University professors Harlan Krumholz and Joe Ross, urged FDA to take a cautious approach in increasing its reliance on surrogate markers, smaller and shorter trials, and evidence derived ...
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    FDA Official Highlights Foreign Supply Chain Challenges

    Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research. Speaking at the Food and Drug Law Institute's annual conference on Friday, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers, which fi...
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    Generic Drug Industry Group Seeks FDA Regulation Changes

    The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce. In addition to citing a lack of clarity in the regulations governing the permitting processes of large life sciences projects, David Gaugh, SVP for sciences and regulatory affairs at AAM, called for five actions to reduce the regulatory bu...