All Regulatory Rapporteur articles in May 2025
View all stories from this issue.
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JournalNavigating orphan drug designation in the EU
Orphan drug designation (ODD) is granted to help with the development of treatement for rare diseases. In this article, ODD’s legal framework and its benefits and challenges are explored.
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JournalNavigating the FDA’s platform technology designation: Key insights and best practices for drug manufacturers
This article discusses the platform technology designation (PTD) initiative, including its key elements, challenges and its overall significance.
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JournalPrescribing efficiency: Using generative artificial intelligence for pharmacovigilance
Pharmacovigilance stands as a cornerstone of patient safety but the processes can be arduous. This article explores how generative AI can optimise workflows, reduce reporting burdens and improve timeliness.
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JournalCase studies: The impact of the In Vitro Diagnostic Regulation on ATMP clinical trials and drug development plans
This article looks at the impact of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and uses case studies to help improve ATMP development.
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JournalRecent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment
With ATMPs bringing new promise to the treatment of cancer, this article assesses recent clinical developments, how regulators are responding to these advances and how this will impact patient access in the future.
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EditorialAdvanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
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JournalGene Therapy Medicinal Products: An examination of regulatory CMC requirements
This article explores the CMC requirements for GTMPs to help ensure high quality and safe products are brought to market.