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2 min read

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 data from “preclinical tests ” to prove their drug is safe enough to advance to testing in humans. At the close of last year, Food and Drug Omnibus Reform...

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4 min read

Regulatory Guidance Monthly Review - February 2023

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...

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1 min read

European Medicines and Medical Devices: Future Trends

Based on an online seminar presentation made in collaboration with TOPRA and Veristat, this article dives into the future of the European medicines and medical devices industry and the changes in legislation that are being prompted by the evolving...

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Emergency Use Authorizations

Emergency Use Authorizations (EUA) are a mechanism that allows the U.S. FDA to facilitate the availability of medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) threats, including emerging infectious diseases such as...

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1 min read

Podcast: Orphan Drug Designations and Orphan Subsets

Sponsors developing drugs or biologics intended to prevent, diagnose, or treat a rare disease or condition should consider applying for the Orphan Drug Designation (ODD) program with the FDA. The FDA’s Orphan Drug Designation program is meant to...

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4 min read

Regulatory Guidance Monthly Review - January 2023

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...

READ MORE

4 min read

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 clinical development pathway. These teams routinely benefit from the support of an external partner who can minimize the risks of failure and missed...

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2 min read

On-Demand Webinar: Decentralized Trial Solutions for Complex Clinical Trials

Decentralized clinical trials (DCTs) are becoming increasingly popular to optimize patient engagement and retention. At the same time, making DCTs a successful reality for the most complex studies is considered difficult given the many logistical and...

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5 min read

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 participate in this invite-only program. It is part of our company’s DNA to stay ahead of the driving forces in the industry so that we can best serve as a...

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2 min read

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 to the National Institutes of Health (NIH)? That’s 30 million people in the US, and similarly in the EU affected.Before 1983 in the US and 2000 in the EU,...

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