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  • 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    Industry groups and drugmakers are seeking further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the qualification of biomarkers.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 ...
  • Regulatory NewsRegulatory News

    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...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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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    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...
  • Regulatory NewsRegulatory News

    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...
  • 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...
  • IOM Releases Report on Biomarkers and Surrogate Endpoints

    The Institute of Medicine (IOM) released a workshop summary on 14 February that explores the evaluation process for biomarkers used to detect surrogate endpoints in chronic diseases. An initial report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease , was requested by the US Food and Drug Administration (FDA), and released by IOM in May 2010. Biomarkers are "indicators of normal biological processes, pathogenic processes or pharmacologic response...