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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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1 min read

Is it Possible to Gain Regulatory Approval Following a Single-Arm Study?

In this case study example - yes.

Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...

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1 min read

Veristat Joined the Battle Again - in 2022

Another Successful Cycle for Survival Ride Raising $90K To Support Rare Cancer Research

 

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2 min read

Strategic Resourcing | Another Way To Help Sponsors

Staffing solutions to accelerate clinical development milestones and support study success

 

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2 min read

Regulatory Guidance Monthly Review

February 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...

READ MORE

3 min read

Regulatory Guidance Monthly Review - Jan2022

January 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...

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3 min read

Regulatory Guidance Monthly Review - Dec 2021

December 2021 

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...

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3 min read

Regulatory Guidance Monthly Review - Nov 2021

November 2021 

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...

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3 min read

Regulatory Guidance Monthly Review - Oct 2021

October 2021 

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...

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3 min read

Regulatory Guidance Monthly Review - Sept 2021

September 2021 

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...

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