Premarket Approval Application (PMA) Archives

3 Ways Remote Site Monitoring Can Increase Regulatory Compliance for Your Study

Business, Clinical Researchers, Clinical Trials, Compliance, Contract Research Organization (CRO), Coronavirus Disease 2019 (COVID-19), FDA, Life Sciences, New Drug Application (NDA), Premarket Approval Application (PMA), Software, Technology

Andrea Bastek – Director of Innovation at Florence, the largest eISF + Remote Site Access platform in clinical research – discusses three ways in which sponsors and CROs can increase compliance with a purpose-built, site-centric, remote access platform.

Breast Cancer Device Receives FDA Approval

Approvals, Breast Cancer, FDA/Regulatory, Hospitals, Lesions, Medical Devices, Premarket Approval Application (PMA), Tumors

The U.S. Food and Drug Administration approved the first non-radioactive, dual-tracer for sentinel lymph node biopsy.

FDA Approves World’s First Long-Term Implantable Continuous Glucose Monitoring System

Approvals, Blood Glucose Monitoring System, Diabetes, FDA/Regulatory, Premarket Approval Application (PMA)

The U.S. FDA approved Senseonics Holdings’ Premarket Approval application to market the company’s Eversense Continuous Glucose Monitoring System to people with diabetes.