• Regulatory NewsRegulatory News

    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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    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...
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    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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    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...
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    Breaking Bottlenecks: FDA Clarifies Tool for Expediting Drug Development (Corrected)

    The US Food and Drug Administration (FDA) is trying to clarify how industry can request a meeting of the agency's Critical Path Initiative (CPI), a decade-old effort to accelerate drug development through the use of common standards. Correction: A previous iteration of this article suggested that FDA's effort under the Critical Path Initiative, as well as its Critical Path Innovation Meetings (CPIM), were connected with the Critical Path Institute (C-Path)—a public-priv...
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    FDA Unveils Pilot Program Aimed at Accelerating Approvals of New Medical Devices

    The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals. Background Regulators have long been interested in making sure that tools and measures used during the medical device development process are validated -- that is, proper for use and fit for purpose within a specific context. Many clinical trials are ultimately scrapped...
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    Establishing Effective Device Supplier Qualifications

    Supplier qualification is an important quality system requirement that, when performed effectively, ensures with a high level of confidence that a purchased product will consistently meet specified requirements. An effective supplier qualification procedure should include risk analysis, quality auditing and the use of qualified analytical test methods and statistical techniques to determine supplier capability. A risk score assigned to suppliers, based on the result of s...
  • FDA Creates Program to Boost Regulatory Science, Speed Drug Development

    The US Food and Drug Administration (FDA) is announcing the launch of a new program that it hopes will help to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development. The program, which FDA is calling the Drug Development Tools (DDTs) Qualification Program, is being run by FDA's Center for Drug Evaluation and Research (CDER). The Center sees the program as "a mechanism for formal review by CDER to qualify drug de...