September 2025 – Contents
Reimagining product information
Product information: An overview
The EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future
Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals
What could the future of labelling look like? The Gravitate-Health story
Translating real-world needs into digital medication tools: Good practices for co-creation with patients
Digital transformation of global regulatory affairs: Then, now and next
Target product profile and product profile characteristics for labelling during drug development
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Survey shapes Regulatory Rapporteur’s future plans
An update on how readers’ feedback is informing future developments for Regulatory Rapporteur.
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 industry news update discusses George Francis Tidmarsh, M.D., Ph.D., who has been appointed as Director of the Center for Drug Evaluation and Research.
More news
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.
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.
RegRapPod − InConversation with Zohra Nasir and Aksa Rahman
InConversation talks careers with Zohra Nasir and Aksa Rahman
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