All North America articles
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ContentsRegulatory Rapporteur November 2026 – Contents
The November issue of Regulatory Rapporteur focuses on the Americas.
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JournalThe end of the two-tier system: A comparative review of the FDA’s 2024/2025 shift on biosimilar interchangeability and its impact on global harmonisation
This article analyses the FDA draft guidance changes for 2024 and 2025 and assesses how these modifications may affect market competition and international regulatory harmonisation
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JournalThe FDA Quality Management System Regulation and the limits of harmonisation: Building a global QMS around a common core
Following the implementation of the FDA’s Quality Management System Regulation, this article uses the US as a worked example to examine the extent to which the region had joined the international mainstream and what still differs
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JournalMapping early and often FDA interaction in rare disease programmes: Building the path from discovery to registration
This article explores the challenges unique to rare disease development and presents an overview of key FDA interaction opportunities and regulatory advancements
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JournalNavigating the fragmented US approach to AI governance: What FDA guidance, State legislation, and divergence from the EU AI Act mean for regulatory teams
This article examines the emerging US AI governance framework, contrasts it with the EU AI Act, and considers how regulatory teams can build systems capable of addressing divergent global requirements without unnecessary duplication of controls, evidence and oversight
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Industry newsFDA introduces new pilot programme to accelerate early-stage clinical research
The US Food and Drug Administration (FDA) has outlined a series of actions to accelerate and modernise clinical research from the Investigational New Drug phase through to late-stage pivotal studies.
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Industry newsFDA launches final guidance on therapeutic equivalence evaluations
The US Food and Drug Administration (FDA) has issued its final guidance on making therapeutic equivalence evaluations and assigning therapeutic equivalence (TE) codes.
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Industry newsFDA consults on the regulation of GenAI-enabled medical devices
The US Food and Drug Administration (FDA) has released a discussion paper to gather feedback on topics relevant to the regulation of generative artificial intelligence (GenAI)-enabled medical devices.
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Industry newsFDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
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Industry newsFDA launches new guidance on development of psychedelic drugs to treat medical conditions
The US Food and Drug Administration (FDA) has issued its final guidance for drug development programmes evaluating the therapeutic potential of psychedelic drugs.
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Industry newsUSP 2025 Annual Drug Shortages Report: Shortages decline but duration increases
In June 2026, the United States Pharmacopeia (USP) released their 2025 Annual Drug Shortages Report, reviewing trends in drug shortages affecting the United States.
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Industry newsFDA launches Operation TrialBlazer to accelerate US clinical research
The US Food and Drug Administration (FDA) has announced plans to revitalise clinical research in the USA, as part of a US Department of Health and Human Services (HHS) initiative titled ‘Operation TrialBlazer’. The FDA has proposed multiple actions to achieve this aim, targeting both early- and late-stage ...
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ContentsRegulatory Rapporteur July/August 2026 – Contents
The July/August issue of Regulatory Rapporteur focuses on therapeutics.
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JournalDrug development and regulatory pathways across therapeutic areas
This article evaluates how drug development and regulatory pathways differ across oncology, rare diseases, paediatric indications and life-threatening conditions in the US, UK and EU. Drawing on regulatory guidance and industry practices, it explores how therapeutic context shapes development, trial design and approval strategies, highlighting key differences in regulatory expectations and acceleration incentives.
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Industry newsHarmonisation, fast track and reliance activities in focus at recent EDQM meetings
Leaders from the European Directorate for the Quality of Medicines & HealthCare (EDQM), which is home to the European Pharmacopoeia (PhEur), participated in two public outreach events in May 2026. The first was on pharmacopoeial harmonisation in collaboration with United States Pharmacopoeia (USP), and the second on fast ...
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JournalEmergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
This article explores the FDA’s Emergency Use Authorisation framework and its aim to speed up the deployment of IVDs during public health emergencies, focusing on its evolution, operational mechanisms and significance in public health preparedness.
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JournalThe regulatory valuation of patient experience data in rare diseases: A review of FDA and EMA labelling outcomes and methodological determinants
This article summarises a review carried out to evaluate patient experience data inclusion in regulatory assessements and labelling for rare diseases in the EU and the US
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Industry newsFDA advances commitment to moving beyond animal testing
The US Food and Drug Administration has published draft guidance establishing four core validation principles for new approach methodologies in drug development, marking another milestone in its commitment to reducing animal testing in drug safety assessment.
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JournalA year of change for the US FDA: An update on notable pilots and programmes
This article updates on the FDA’s pilots and programmes that have been launched and also ongoing projects in 2025.
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ContentsRegulatory Rapporteur December 2025 – Contents
The December issue of Regulatory Rapporteur focuses on North America.