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Regulatory Submissions (8)

3 min read

Regulatory Guidance Monthly Review - October 2019

October 2019 Updates from FDA 

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,...

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4 min read

Regulatory Guidance Monthly Review - September 2019

September 2019 Updates from FDA 

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,...

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3 min read

Regulatory Guidance Monthly Review - August 2019

August 2019 Updates from FDA 

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,...

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2 min read

Regulatory Guidance Monthly Review - July 2019

July 2019 Updates from FDA 

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,...

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2 min read

Regulatory Guidance Monthly Review - June 2019

June 2019 Updates from FDA 

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,...

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2 min read

Regulatory Guidance Review - May 2019

May 2019 Updates from FDA 

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) and European Medicines Agency (EMA) that are pertinent to the governance of...

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2 min read

Regulatory Guidance Review - April 2019

Latest Updates from FDA & EMA

April 2019 Updates

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) and European Medicines Agency (EMA) that are pertinent...

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2 min read

Regulatory Guidance Review

Latest Updates from FDA & EMA

March 2019

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) and European Medicines Agency (EMA) that are pertinent to the...

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3 min read

Is Your Complex NDA/MAA Submission Missing One of These Key Elements?

Veristat has experience in preparing more than 120 marketing applications.  Our exposure to in creating new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:

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3 min read

Key Strategies for Overcoming Data Analysis Difficulties During NDA/MAA Submissions

When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), it seems there is no alternative but to take a hit to the timeline — or is there?

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