Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...

African National regulatory agencies (NRAs) under the World Health Organisation’s (WHO) maturity level 3, have signed a ...

Senseonics has filed to obtain CE Mark registration for its one-year continuous glucose monitoring (CGM) system, Eversense 365. The CE Mark submission aligns with the EU Medical Device Regulation (MDR ...

New Partnership for Africa’s Development (AUDA-NEPAD) and the Africa Centres for Disease Control and Prevention (Africa CDC) ...

W. Edwards Deming Quality culture is a cornerstone of any industry, particularly the healthcare industry where patient lives ...

GlobalData’s director of therapy research & analysis in medical devices says the new entity could make an attractive ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for ...

The new ACC and AHA criteria for cardiac devices emphasize more risk stratification, reflecting advances in the field in ...