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...
Weighing the Suitability of a Functional Service Provider (FSP) Model for Clinical Trials
Clinical and regulatory teams face increased pressure to drive uninterrupted progress across the...
On-Demand Webinar: Decentralized Trial Solutions for Complex Clinical Trials
Decentralized clinical trials (DCTs) are becoming increasingly popular to optimize patient...
Laying the Groundwork to Measure the Impact of Decentralized Clinical Trials (DCTs)
The Tufts CSDD Roundtable took place in November, and on behalf of Veristat, I was honored to...
On-Demand Webinar: Orphan Drug Designation - The Considerations, The Rewards, and How They Differ Between The US and Europe
Did you know approximately 1 in 10 Americans are affected by a rare disease or condition according...