Category: Regulatory & Safety
Prepare Now for EU Clinical Trial Regulation Go-Live Date
Devices/Diagnostics: Emergency Use Authorizations During the COVID-19 Pandemic
REMS: To Outsource or Not to Outsource?
New and Emerging Regulatory Guidance for Cell and Gene Therapy Product Development
The Critical Need for Pregnancy Registry Studies and Robust Safety Monitoring in COVID-19 Vaccines
Predicting Extractables & Leachables Amounts Using Mathematical Modeling
Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
Time to Act is Now: Paediatrics Medicines Development in the UK
Mitigating Impacts of a Global Pandemic in the Clinical Development Space