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More than a statistic: What EU Joint Clinical Assessment changes for oncology patients
This article by Dr. Liz O’Brien of ICON, outlines how the EU Joint Clinical Assessment is reshaping global oncology drug development by driving earlier evidence generation, strengthening patient‑centered trial design and enabling more equitable access to innovative treatments across Europe. It underscores the growing emphasis on patient insights, PROs and cross‑functional evidence planning one year after JCA implementation.
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How digital health technologies are reshaping clinical development
Digital health technologies are rapidly becoming essential to clinical trial strategies as regulators and sponsors embrace them to streamline operations, reduce patient burden, and generate higher‑quality real‑world data.
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Submitting clinical data to the FDA and PDMA: An efficient and compliant approach
In this article, our data standards experts explain how sponsors can efficiently prepare clinical data submissions that meet both FDA and PMDA requirements by leveraging the substantial alignment between the two agencies’ standards.
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Pharma communications resilience: Navigating regulatory policy shifts with strategic precision
Regulatory change often brings unexpected challenges to an already complex environment. Product labelling is no exception. Yet, with the right foundation, organisations can transform uncertainty into opportunity. A well-balanced mix of skilled personnel, timely intelligence and agile processes equips organisations to stay ahead of regulatory shifts.
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Formulation Strategies, Tech Advances, Challenges and Considerations in Novel Drug Delivery
The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.
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Regulatory strategy reimagined: Three trends accelerating drug development
The regulatory landscape is being rewritten. The future belongs to those who anticipate, adapt and act with purpose. In this article we look at 3 macro trends that are redefining regulatory strategy.
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CRO reforms: Tilting scale towards accelerated growth and transparency
The article, featuring commentary from Nagalakshmi Shetty, highlights how India's clinical research sector is rapidly expanding. Regulatory reforms like the Central Drugs Standard Control Organisation's NDCR (Amendment) Rules 2024, mandatory CRO registration and digitised portals are boosting transparency, shortening approval timelines and positioning India as a global hub for clinical trials.
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Impact assessment is the first, critical step to updated ICH GCP compliance
ICH GCP E6(R3) is here. In the latest issue of PharmaTimes, ICON explores why a comprehensive impact assessment is the essential first step toward strategic compliance.
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How cancer regulation is — and isn’t — changing at FDA: a BioCentury podcast
Dr. Liz O’Brien, Senior Director of Global Drug Development at ICON and former EMA regulator, joined the BioCentury This Week podcast to share insights on navigating FDA’s Project Optimus, the EMA’s Joint Clinical Assessment and highlight the key differences between the two regulatory regimes.
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Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
In a recent interview with Citeline, the head of ICON's Centre for Biosimilar Drug Development discussed the upcoming patent expirations in oncology biologics, the opportunities, regulatory pathways and challenges this presents for developers and greater treatment access for patients.
