Category: Regulatory & Safety

Five Challenges and Solutions in mRNA Vaccine Manufacturing

Getting Ahead in mRNA Vaccine Development with an Experienced CRO Partner

Registries for Regulatory Decision-Making: Comparing EMA and FDA Guidance on Real-World Evidence

A Look Inside China’s Innovative Drug Applications

Success Factors for eCTD Implementation in Mainland China and Taiwan

European Union Clinical Trials Regulation: Clinical Trials Information System

New European Union Regulation to Change How Clinical Trials are Conducted

Fast-Tracking Pediatric Development Plans for COVID-19 Vaccines and Treatments

Estimands in Oncology Trials