• Regulatory NewsRegulatory News

    Drugmakers Seek More Clarity From FDA on Biomarkers With Multiple Applications

    Industry groups and drugmakers are seeking further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the qualification of biomarkers. The draft from last December , which FDA emphasizes is a first draft, comes as FDA has qualified  eight biomarkers  and received  29 submissions . The draft notes that progress in biomarker qualification has been stymied by the lack of a clear, predictable and specific regulatory framework that lays out ...
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    Advances in Sequencing Likely to Shift Paradigm in Cancer Drug Approvals, FDA Experts Say

    Experts within FDA's newly established Oncology Center of Excellence (OCE) discussed the office's role in the first site-agnostic cancer treatment approval and programs for further advancing oncology-related regulatory science and policy. And in the concluding section of the article, the OCE experts note that FDA, which has typically approved companion diagnostics under a "one drug, one diagnostic" paradigm, is "likely to" shift to a "many drugs, a panel of diagnos...
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    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
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    FDA Offers Biomarker Qualification Case Studies

    As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers. One follows a researcher who discovers a promising biomarker of drug-induced kidney injury in rats and explores how he partnered with rese...
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    FDA, NIH Unveil Initial Framework for Biomarker Qualification

    Officials from the US Food and Drug Administration (FDA), the Foundation for the National Institutes of Health (NIH) and other stakeholders, including experts from Genentech, Merck, Pfizer and Takeda, have released a framework for proposed evidentiary criteria to support the regulatory acceptance of biomarker use in drug development programs. The framework, released 6 December, is expected to help support FDA in the development of relevant guidance(s) for evidentiary cr...
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    Biomarkers Used as Outcomes: FDA Wants to Hear More on Examples

    The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in development of FDA-approved new molecular entities and new biological therapeutics. The comments, which should be submitted by 18 November , may assist FDA in developing databases on biomarkers for drug development in the future, the agency said. Background Biomarkers are frequently use...
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    Total Kidney Volume Qualified as a Biomarker by FDA for ADPKD Trials

    The US Food and Drug Administration (FDA) on Thursday released new guidance providing a qualified context for use for the biomarker total kidney volume (TKV) in studies for the treatment of the common, life-threatening genetic disease known as autosomal dominant polycystic kidney disease (ADPKD). According to the PKD Foundation , ADPKD is the fourth leading cause of kidney failure, and more than 50% of people with ADPKD will develop kidney failure by age 50. And accord...
  • Feature ArticlesFeature Articles

    The New KYSS Principle: Know Your Supplier's Supplier

    • 27 May 2016
    This article introduces the KYSS principle to align a robust supplier management program with regulatory requirements and includes initial identification and qualification of suppliers, supplier quality agreements and both initial and ongoing supplier monitoring. Introduction Deaths, illnesses, injuries and many recalls have been attributed to fraudulent, counterfeit or adulterated components of finished pharmaceuticals and medical devices. 1 These tragic consequence...
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    Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development

    Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said. Biomarkers are biological characteristics that can be measured to give an indication of a biological process or the presence or likelihood of a disease.  They can also predict how a patient might respond to a particular inter...
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    FDA, NIH Unveil Glossary of Clinical Definitions

    A joint US Food and Drug Administration (FDA), National Institutes of Health (NIH) Leadership Council has released a glossary of definitions, meant to clarify and describe some of the relationships, connections and distinctions among terms used in translational science and medical product development. The council’s development of the glossary is part of the first phase of its BEST (Biomarkers, Endpoints, and other Tools) Resource and aims to capture differences between b...
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    EU Makes Major Update to Drug Manufacturing Guidelines

    For the first time since 2001, the European Commission (EC) is updating its guidelines for pharmaceutical qualification and validation . The update to EurdraLex Volume 4, Annex 15: Qualification and Validation goes into effect on 1 October 2015. The new version accounts for significant changes in the regulatory environment and will align with guidelines from the International Conference on Harmonisation (ICH). Background Annex 15 contains the requirements for qua...
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    Can Drug Development be Accelerated? FDA Wants Help

    The US Food and Drug Administration (FDA) is soliciting input on how it might accelerate the development of certain drug products through the use of new and emerging biomarkers. Background In FDA's telling, a qualified biomarker —"an objective characteristic that is measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to treatment"—can help drug development in several ways. For example, a biomarker migh...