Category: Regulatory & Safety

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

Regulatory Post-Approval Change Management in China

COVID Elucidates the Need for Pregnancy Safety Studies

Five Key Decision Points That Set You Up for Commercial Success