Blog | Veristat Insightful Perspectives

Regulatory Guidance Monthly Review - December 2020

December 2020 



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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in December 2020.

 

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Adapting Human Connection in a Virtual World

How We Planned an International Meeting in a Pandemic

Looking back, 2020 has taught us all a few lessons we were not expecting to learn.

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Regulatory Guidance Monthly Review - November 2020

November 2020 



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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in November 2020.

 

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Regulatory Guidance Monthly Review - October 2020

October 2020 



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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in October 2020.

 

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Regulatory Guidance Monthly Review - September 2020

September 2020 



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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in September 2020.

 

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Regulatory Guidance Monthly Review - August 2020

August 2020 



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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in August 2020.

 

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Regulatory Guidance Monthly Review - July 2020

July 2020 



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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in July 2020.

 

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Regulatory Guidance Monthly Review - June 2020

June 2020 



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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in June 2020.

 

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Regulatory Guidance Monthly Review - May 2020

MAY 2020 



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 and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in May 2020.

 

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EMA Guidance on Management of Clinical Trials during COVID-19 Pandemic

Summary of Key Considerations Outlined in the Third Edition of the EMA Guidance

 

The European Medicines Agency (EMA) has now published its third version of the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic.  This guidance addresses the need for sponsors to change the execution of clinical trials during the global COVID-19 pandemic response. 

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