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Regulatory Submissions

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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4 min read

Regulatory Guidance Monthly Review - September 2022

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...

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4 min read

Regulatory Guidance Monthly Review - August 2022

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...

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1 min read

Planning the Way Forward for a New Tumor Evaluation Modality

RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...

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4 min read

Regulatory Guidance Monthly Review - July 2022

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...

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4 min read

Regulatory Guidance Monthly Review - June 2022

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...

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5 min read

Regulatory Guidance Monthly Review - May 2022

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...

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2 min read

Regulatory TOPRA Webinar: Latest Regulatory Experiences

Each year, Veristat regulatory experts present timely, relevant topics to members of The Organization for Professionals in Regulatory Affairs (TOPRA), a UK-based organization committed to driving regulatory excellence across the healthcare regulatory...

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5 min read

Regulatory Guidance Monthly Review - April 2022

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...

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