• RF Quarterly

    Synthetic data and the innovation, assessment, and regulation of AI medical devices

    Synthetic data are artificial data that mimic the properties of, and relationships in, real data. They show promise for facilitating data access, validation, and benchmarking, addressing missing data and under-sampling, sample boosting, and the creation of control arms in clinical trials. The UK Medicines and Healthcare products Regulatory Agency (MHRA) is using its current research into the development of high-fidelity synthetic data to develop its regulatory position on ...
  • 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    Industry groups and drugmakers are seeking further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the qualification of biomarkers.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 ...
  • RAPSRAPS' 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...
  • Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
  • 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...
  • Feature ArticlesFeature Articles

    Pharmaceutical Cleaning Processes

    This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification. Introduction I really like my new stainless steel dishwasher. It has lots of cool, blinking blue lights, many intriguing buttons and a variety of cycles. It also performs magic. I put dirty dishes in, add detergent, push the right buttons and voila! Dishes, glasses, knives and forks all come out clean about an hour later. Technology s...
  • 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

    MHRA Details Common Issues in Clinical Trial Applications

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays. According to the agency, more than half of the approximately 1,000 clinical trial applications submitted each year require additional information before they can be reviewed and approved. While MHRA typically reviews clinical trial applications for ...
  • 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...
  • Feature ArticlesFeature Articles

    Process Validation Review: How Many Ways Can You Bake a Pie?

    This article explains process validation in a fun way using pie baking as an analogy. If you are like me, you cook for Thanksgiving. In my family, I am expected to make several pies and my favorite is Kentucky Pie, a cross between chocolate chip and pecan pie—yummy! Every year, it turns out different. Some years, I make it with bourbon, some without and sometimes with cornmeal instead of flour. Each time it is pretty good, but different because I like to be creative. W...
  • 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...