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Regulatory Guidance Monthly Review - October 2019

November 6, 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, biologic, or medical device development and approval.   Below are the relevant links to updates provided in October 2019.

 

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Regulatory Guidance Monthly Review - September 2019

October 2, 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, biologic, or medical device development and approval.   Below are the relevant links to updates provided in September 2019.

 

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Regulatory Guidance Monthly Review - August 2019

September 3, 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, biologic, or medical device development and approval.   Below are the relevant links to updates provided in August 2019.

 

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Regulatory Guidance Monthly Review - July 2019

August 2, 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, or medical device development and approval.   Below are the relevant links to updates provided in July 2019.

 

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Regulatory Guidance Monthly Review - June 2019

July 10, 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, or medical device development and approval.   Below are the relevant links to updates provided in June 2019.

 

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Regulatory Guidance Review - May 2019

June 6, 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 clinical trials and drug, biologic, or medical device development and approval.   Below are the relevant links to updates provided in May 2019.

 

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Regulatory Guidance Review - April 2019

May 8, 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 to the governance of clinical trials and drug, biologic, or medical device development and approval.   Below are the relevant links to updates provided in April 2019.

 

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Regulatory Guidance Review

March 28, 2019

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 governance of clinical trials and drug, biologic, or medical device development and approval.   Below are the relevant links to updates provided in March 2019.

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

August 21, 2018

By Martha Plaza, MBA; Amanda Truesdale, MA, MBA; and Kimberly Newton, MA. 

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

August 14, 2018

By Amanda Truesdale, MA, MBA, VP Biometrics

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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