Regulatory Approval Pathways

FDA Approval Process for Companion Diagnostics

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Companion diagnostics (CDx) are essential tools that identify which patients are likely to benefit from a specific therapeutic product. In the United States, the U.S. Food and Drug Administration (FDA) regulates CDx as in vitro diagnostic (IVD) devices under the Federal Food, Drug, and Cosmetic Act (FDCA). For a CDx to be marketed, especially when it is required for the safe and effective use of a corresponding therapeutic product, it must undergo a rigorous FDA review and approval process.
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways

EU IVDR and Its Impact on Diagnostics Trials

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The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) replaced the previous IVDD (Directive 98/79/EC) and entered into force on May 26, 2022. The IVDR introduces significant changes in the classification, conformity assessment, performance evaluation, and clinical evidence requirements for in vitro diagnostics (IVDs), including companion diagnostics (CDx).
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways

PMDA and Asia-Pacific Approval Pathways

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As the pharmaceutical market continues to expand across Asia-Pacific (APAC), countries like Japan, China, South Korea, and Australia have introduced specific regulatory frameworks for companion diagnostics (CDx). For global clinical trials and commercialization strategies, understanding the approval processes under authorities such as Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) is essential.
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways

Harmonizing Drug-Diagnostic Co-Submissions Globally

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As personalized medicine becomes mainstream, companion diagnostics (CDx) play a critical role in selecting the right therapy for the right patient. However, regulatory authorities across the globe have distinct timelines, technical requirements, and processes for approving a drug and its associated diagnostic. These differences can hinder the simultaneous global launch of precision therapies.
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways

Timeline Management for Regulatory Submissions

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Companion diagnostics (CDx) are essential in ensuring targeted therapies reach the right patients. However, global approval pathways involve distinct submission formats, timelines, and regulatory expectations. Without structured timeline management, developers risk delays in therapy launches, regulatory rejections, and increased costs.
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways

Labeling Requirements for Companion Diagnostics

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Labeling for companion diagnostics (CDx) is more than just a product insert — it’s a critical regulatory document that links the diagnostic to its intended therapeutic product. Regulatory authorities such as the FDA, EMA, and PMDA place significant emphasis on precise, consistent, and evidence-supported labeling to avoid misleading claims and ensure safe use.
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways

Bridging Studies for International Regulatory Submissions

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In companion diagnostics (CDx) and other regulated in vitro diagnostics (IVDs), a bridging study demonstrates that results obtained with a new test system, cut-off, matrix, site, or population are clinically and analytically comparable to those used to generate pivotal evidence. Sponsors use bridging when moving from a development assay to a commercial kit, from one instrument or reagent lot to another, or when seeking approval in a new region where local conditions or populations differ. The goal is to show that the medical decisions derived from the “bridged” configuration are as safe and effective as those from the reference configuration.
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways

Preparing IDE Submissions for Diagnostic Tools

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An Investigational Device Exemption (IDE) allows a diagnostic device—such as a companion diagnostic (CDx), imaging agent readout, or standalone in vitro diagnostic (IVD)—to be used in a clinical investigation to collect safety and effectiveness data. In drug development, diagnostics frequently determine patient eligibility, stratify cohorts, or guide dosing. If the test result will influence a subject’s medical care or enrollment in a way that could pose risk, U.S. regulations generally require IDE oversight. Sponsors (device manufacturers or drug co‑developers) are responsible for design control, monitoring, safety reporting, and quality management, while investigators and sites implement the protocol and protect subjects under IRB oversight and informed consent requirements.
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways

Real‑World Evidence in Diagnostic Regulatory Submissions

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Real‑world evidence (RWE) refers to clinical insights generated from data collected outside tightly controlled trials—such as electronic health records (EHRs), laboratory information systems (LIS), claims, registries, biobanks, and pragmatic or decentralized studies. For companion diagnostics (CDx) and other IVDs, RWE can confirm performance in diverse practice settings, characterize rare variants or phenotypes, and demonstrate that an assay’s real‑world use supports the same medical decisions described in its labeling. Regulators increasingly accept well‑designed RWE to complement clinical performance studies, justify label expansions (e.g., new tumor types or specimen matrices), or support bridging when a trial‑stage assay differs from the marketed configuration. Crucially, RWE is not a shortcut; agencies expect traceable provenance, pre‑specified analysis plans, and bias‑mitigation strategies that elevate observational data to decision‑grade evidence.
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Biomarkers and Companion Diagnostics, Regulatory Approval Pathways