Lead Story
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.
Industry news
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.
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.
More news
NHS app opens access to trials for UK patients
Updated post-market surveillance requirements take effect
FDA to replace animal testing with new approach methodologies
EMA to address antimicrobial resistance risks from veterinary medicinal products
MHRA authorises new cancer treatment variation with significantly reduced administration time
