Blog | Veristat Insightful Perspectives

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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Clinical Trial Conduct During COVID-19 Pandemic Response

Key Lessons Learned during the First Month of the COVID-19 Pandemic Response 

As we are well-rooted in the response phase of the COVID-19 pandemic, we have seen a flurry of sponsors looking through their pipelines to find either approved or investigational products that could help treat, diagnose or prevent COVID-19.   As such, Veristat spent the first four weeks of the pandemic response supporting five clinical research programs for COVID-19 vaccines and treatments.   And, we are rapidly fielding daily requests for more programs.   

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Regulatory Guidance Monthly Review - April 2020

April 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 April 2020.

 

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Regulatory Guidance Monthly Review - March 2020

March 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 in March 2020.

 

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MRHA Guidance for Clinical Trials During COVID-19 Outbreak

MHRA Guidance On Clinical Trial Conduct During COVID-19 Pandemic 

 

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