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In the News
ICON experts frequently author or contribute to industry trade press.
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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.
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Regulatory Strategy, The Maestro
As part of Pharma Tech Outlook's Regulatory Strategy, The Maestro Q&A series, ICON answers a range of questions around regulatory in clinical trials, timing and other considerations.
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Preparing to Achieve with Joint Clinical Assessments
Since Regulation (EU) 2021/2282 (HTAR) came into effect, HTDs need to plan for a Joint Clinical Assessment (JCA) in addition to submitting their CTD to the EMA or medical device technical file to their notified body. In this article, ICON discusses this new requirement, factors to consider and the benefits.
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Regulatory strategy implications for foetal medicine
In the February edition of TOPRA's Regulatory Rapporteur, ICON summarises the European legislation related to Regulation (EC) 1901/2006 and how it incorporates PIPs but omits the unborn foetus. We also review the guidelines and other application precedents while providing insight into distinctions that may be made by the agency in this matter, as well as highlighting relevant precedents which were identified during this peer reviewed article.
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Set for success. Avoiding the pitfalls of clinical data conformity in medical device trials
It would seem intuitive that in order to pass a clinical trial and be compliant with EU MDR/IVDR, the trial data would need to conform to the processes and rules set out by the Notified Bodies. Surprisingly, in practice this is not always the case. Learn more about potential pitfalls and how to mitigate against them.
