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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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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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Regulatory Insights on COVID-19 Updates From FDA | 31 March 2020

FDA UPDATES -  For Sponsors with Products Intended to Treat Indications Other than COVID-19

 

In this unique time, with many health authorities, governments and pharmaceutical companies focused on the global pandemic and how to prevent, diagnose and treat COVID-19, it is important to remember the number of therapies currently in development or already approved for the multitude of other diseases affecting people worldwide.  FDA has issued several press releases and guidance that affect Sponsors running or planning clinical studies, those planning marketing applications and those with products already on the market.  We summarize here valuable information that is important for drug and biologic companies to be aware of as they continue to try to make these therapies available to patients. 

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Covid-19 Update from FDA | Conduct of Clinical Trials During Covid-19 Outbreak

FDA Guidance On Clinical Trial Conduct During COVID-19 Pandemic -  18 March 2020 

 

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Regulatory Guidance Monthly Review - February 2020

February 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 February 2020.

 

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Regulatory Guidance Monthly Review - January 2020

January 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 January 2020.

 

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Regulatory Guidance Monthly Review - December 2019

December 2019 



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 December 2019.

 

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Regulatory Guidance Monthly Review - November 2019

November 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, or medical device development and approval.   Below are the relevant links to updates provided in November 2019.

 

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