Dedicated Regulatory Project Management
Drug developers hire regulatory consultants and CROs to help navigate the complex regulatory agency...
Regulatory Guidance Monthly Review - March 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Bold Thinking that Delivers Results for RNA Therapies
Current advances in RNA-based therapies hold substantial promise in treating and preventing many...
CMC Pitfalls: From Benchtop to IND
Successfully transitioning from academic or bench-top production to manufacture clinical-grade...
FDA Introduces New Term "Nonclinical Tests" Signaling a Beginning, Not an End
For the past 60 years, US law has empowered the FDA to require that clinical trial sponsors submit...
Regulatory Guidance Monthly Review - February 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
European Medicines and Medical Devices: Future Trends
Based on an online seminar presentation made in collaboration with TOPRA and Veristat, this article...
Emergency Use Authorizations
Emergency Use Authorizations (EUA) are a mechanism that allows the U.S. FDA to facilitate the...
Podcast: Orphan Drug Designations and Orphan Subsets
Sponsors developing drugs or biologics intended to prevent, diagnose, or treat a rare disease or...
Regulatory Guidance Monthly Review - January 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...