The FDA has cleared the first over-the-counter continuous glucose monitor for children as young as two who do not use insulin, establishing OTC Glucose Monitoring Children as a practical new option for families. This

The FDA Medical Device Exemptions target specific unclassified preamendment devices that present minimal risk to patients. By exercising enforcement discretion, the agency no longer expects manufacturers to submit 510(k) premarket notification applications for these products until a formal exempt...

Successful medtech reimbursement strategies must be developed in parallel with regulatory approval, because clearance only confirms safety and efficacy while payers separately decide financial coverage. Investors now routinely demand evidence of sustainable payment pathways long before regulatory...

The pharmaceutical access initiative led by the Beneluxa countries urges EU and EEA Member States to pursue closer coordination on medicine affordability and supply security. By combining forces, nations can protect universal health systems that treat healthcare as a social right while still enco...

AI Regulatory Research Priorities have crystallised around one central requirement: establishing trustworthy performance of artificial intelligence systems across the entire pharmaceutical development and evaluation pathway. Stakeholders from every corner of the European medicines regulatory netw...

Central and Eastern European nations face intensifying demographic pressures, including rapid population aging, shrinking workforces, and heightened security risks that endanger long-term prosperity. In a recent EFPIA statement, health economic security is seen as essential, as targeted healthcar...