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  • RAPS' LatestRAPS' Latest

    Medical Device Validation: What You Need to Know and Why It's Important

    Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...
  • Regulatory NewsRegulatory News

    EMA Seeks Experts on Clinical Data Anonymization

    The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data. "Anonymisation of clinical reports poses a major challenge to those directly involved (pharmaceutical industry, clinical research organizations and EMA) and to those accessing the data (patients, healthcare professionals and academia)," EMA says. Specifically, EMA says it plans to form a new committee, referred to as the Techni...
  • RAPS' LatestRAPS' Latest

    Inadequate Medical Device Validation a Common Problem RAPS Publishes 'How-to' Resource

    Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device manufacturers have to interpret broad and varying definitions within FDA’s regulations and a related guidance document on the topic. Until now, there has been no comprehensive resource to help regulatory and quality professionals, and other stakeholders navigate device validatio...
  • RAPS' LatestRAPS' Latest

    Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History

    The following chapter is an excerpt taken from The Medical Device Validation Handbook . Process and Design Validation—Regulatory Concerns Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process can be validated with a high degree of assurance and approved according to established procedures, as required by 2...
  • RAPS' LatestRAPS' Latest

    Call for Authors: We're Seeking Your Expertise

    • 20 March 2015
    • By
    Looking to expand your career by writing in-depth analyses on regulatory healthcare topics? Then Regulatory Focus wants you. The flagship publication of RAPS, Regulatory Focus is looking for both experienced authors and those new to publishing to write on themes selected by our Board of Editors for their usefulness to healthcare regulatory professionals. Topics cut across the full spectrum of healthcare products—drugs, medical devices, biologics, biotechn...
  • RAPS' LatestRAPS' Latest

    RAPS Seeks Authors for Global Device Strategy Book

    Do you have multinational experience with medical devices, throughout the lifecycle, and want to give back to the profession by authoring chapters for a new book? This new publication entitled, Global Strategy for Medical Devices , will help your colleagues develop and implement a strategy to successfully bring their devices to the global stage. To be considered, please submit your interest to Pam Jones by 10 April 2014. Global Strategy for Medical Devices Chapters ...
  • Study: Nearly Third of all Clinical Trials Results Never Published

    • 30 October 2013
    • By
    The result of nearly one in three large clinical trials remain a mystery five years after they end, claims research published this week in the British Medical Journal (BMJ) , raising significant questions about the obligations companies have to the hundreds of thousands of patients who participated in these trials. Researchers looked at 585 "large" clinical trials-trials with 500 or more registered patients-registered with as of January 2009. Of the 5...
  • Study: Pediatric Clinical Trials Guilty of Publication Bias, NIH Falling Short of Obligations

    An examination of 2,385 completed pediatric clinical trials has found 71% were never published, reports Pharmalot . The study, Pediatric Clinical Trial Registration and Trial Results: An Urgent Need for Improvement , was published in the 23 April edition of the medical journal Pediatrics . The study looked at 3,428 closed studied involving children, of which 2,385 were completed, 28 suspended, 125 terminated and 38 withdrawn. The study's authors, Tatyana Shamliya...
  • PLoS: Publication Bias Present for Antipsychotic Drugs

    • 21 March 2012
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    A study published in the journal Public Library of Science (PLoS ) comparing published and unpublished US Food and Drug Administration (FDA)-registered clinical trials shows the presence of a modest publication bias in favor of antipsychotic drugs being seen as effective. The study, conducted by a group of Oregon-based researchers, investigates whether or not unpublished studies were hiding data that could be seen as unfavorable to the drugs. The study compared 24 FDA-r...
  • Report: Pharma-Funded Science Not Necessarily Biased Towards Drugmakers

    • 27 February 2012
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    A report published in the journal Arthritis & Rheumatism showed no statistical significance between arthritis research funded by pharmaceutical manufacturers and research funded by non-profits or government entities. Thirty-seven of 49 trials (75.5%) sponsored by pharmaceutical manufacturers reported positive outcomes compared to 11 of 16 (68.75%) studies funded by nonprofits, government entities or foundations, reports Reuters . The trials all studied rhe...