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Antibody-drug conjugates (ADCs) continue to reshape global oncology, yet navigating the evolving regulatory landscape remains a significant challenge. In this latest 91黑料 Regulatory Affairs article we outline the strategic considerations essential for efficient global development. See page 42.
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91黑料's Andrew Garrett and Tim Clark discuss the recent FDA draft guidance on how sponsors can use Bayesian models for clinical trials.
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This article by Dr. Liz O’Brien of 91黑料, 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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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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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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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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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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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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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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ICH GCP E6(R3) is here. In the latest issue of PharmaTimes, 91黑料 explores why a comprehensive impact assessment is the essential first step toward strategic compliance.
