July/August 2025 – Contents
Patient voice: Shaping the future of medicine regulation
The evolving landscape of public and patient involvement
Patient involvement in the regulatory area: Insights into national level dialogues
The importance of patient advocacy in the EMA ODD process
Realising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials
Diversity in clinical research: Regulatory considerations and updates
FDA comparability guidance: The impact of cell and gene therapy products
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EFPIA publishes guidance document to help support novel methodology submissions
This industry news update shares the EFPIA’s guidance document to help support the submission process for novel methodologies.
New Director appointed at the FDA’s Center for Drug Evaluation and Research
This insudtry news update discusses George Francis Tidmarsh, M.D., Ph.D., who has been appointed as Director of the Center for Drug Evaluation and Research.
FDA makes labelling changes to opioid products mandatory
This industry news update shares the FDA’s labelling requirements for opioid products and what changes must be applied.
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EMA publishes workplan on how to harness data and AI for public health
This industry news update discusses the EMA’s workplan on how to use data and AI to improve public health.
EMA and ICH call for more real-world evidence in regulatory practices
This industry news update explores the growing need for more real-world evidence and real-world data.
NICE rejects funding for Lecanemab as treatment benefits ‘remain too small’
The National Institute for Health and Care Excellence (NICE) has recently announced that it will not back funding for the Lecanemab due to concerns about its effectiveness.
Extension to ICMRA post-approval change collaborative pilots
This industry news update looks at the collaborative pilots led by the ICMRA and other regulatory agencies.
RegRapPod − InConversation with Zohra Nasir and Aksa Rahman
InConversation talks careers with Zohra Nasir and Aksa Rahman
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