Category: Regulatory & Safety

Using a Medical Monitoring Team to Overcome Challenges of COVID-19

Regulatory Insights: ‘Right First Time’ Approach to Post-Authorization Strategy

Regulatory Insights: Regulatory Intelligence Informs Sound Clinical Trial Strategy

Regulatory Insights: Virtual Trials Gaining Traction in the EU

Regulatory Insights: Focus on China — New Provisions for Drug Registration in 2020

Regulatory Insights: Flexible Regulatory Pathways Accelerating Access to COVID-19 Treatments

Regulatory Affairs: Mitigating COVID-19’s Impact on Clinical Trials

Regulatory Insights: New and Existing U.S. Expedited Development and Emergency Use Pathways for COVID-19 Programs

Virtual Lab Quality Audits: Are They Here to Stay?