Lead Story
Survey shapes Regulatory Rapporteur’s future plans
An update on how readers’ feedback is informing future developments for Regulatory Rapporteur.
Industry news
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.
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.
