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    IMDRF Consults on Use of Registries to Support Device Approval Decisions

    The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making. Background Registries, which can capture outcomes associated with medical device use, were identified by IMDRF in 2014 as having "a significant gap" in optimal use for regulatory decision making. This gap led to the creation of IMDRF Registry Working Group ...
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    Building NEST: New Executive Director, CDRH's Shuren Discuss Plans

    The group of stakeholders building the National Evaluation System for health Technology (NEST) outlined what’s in store for the new future as well as the direction that they want the system to go. "NEST is about how we improve the value, use, and time and cost of using real-world data," Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), explained to attendees of AdvaMed’s MedTech conference in San J...
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    FDA's Woodcock: The Clinical Trials System is 'Broken'

    The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine on Wednesday. The comment came at the end of Woodcock's talk in which she also noted that use of master protocols (ie. protocols for trials that look at multiple therapies in ...
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    FDA Finalizes Guidance on Using Real World Evidence for Medical Device Regulatory Decisions

    The US Food and Drug Administration (FDA) has finalized a slightly tweaked guidance on medical device companies’ use of real-world data (RWD) and real-world evidence (RWE) in winning approvals for their products. FDA says the guidance is meant to explain the "characteristics and sources of RWD and characteristics of RWE that may be sufficient for use in making various regulatory decisions." In addition to the draft guidance, the final guidance includes further clar...
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    FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues

    The US Food and Drug Administration (FDA) has warned Chinese over-the-counter (OTC) drug and cosmetics maker Bicooya Cosmetics Limited over poor sanitary conditions and data integrity issues at its Zhejiang, China facility. The warning letter comes after a four-day inspection of the facility last May that resulted in FDA placing the firm on import alert in late June. During the inspection, FDA says its investigator "observed rodent feces throughout [the] facility," incl...
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    ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

    The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection. ICH says the goal of the guideline, referred to as ICH E19, will be to provide "harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemen...
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    FDA Looks to Standardize PQ/CMC Data and Terminologies

    The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission. FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of th...
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    FDA Warns Chinese API Maker for Data Integrity Issues

    The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year. Background In March, FDA placed Qinhuangdao on import alert as a result of the inspection findings, an action that raised alarms at the World Health Organization (WHO), as the company is the only prequa...
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Tells Manufacturers to Review Quality Systems to Ensure Data Integrity The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity. Offici...
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    FDA Warns Two Drugmakers in China and India for Data Integrity Violations

    The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year. Data integrity has been a growing area of focus for FDA, with an increasing number of warning letters and Form 483s citing data integrity violations, many for manufacturers in China and India. USV Warning Let...
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    European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Asks to Suspend Authorizations of Four Imaging Agents After Reviewing Safety The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many month...
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    FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance

    The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues. In a warning letter dated 17 February, FDA details six violations uncovered during a month-long inspection of the Morton Grove, Illinois facility in January and February 2016. In 2014, FDA issued the site a Form 483 detailing 12 observations covering product testing, recordkeeping and data integrity issues. In a filing ...