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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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What  to Know Before Considering an Adaptive Design Clinical Trial

August 31, 2018

By John Balser, PhD, President, Mark Chang, PhD, Senior Vice President, and Robin Bliss, PhD, Director

The Food and Drug Administration (FDA) has started encouraging the use of adaptive designs for clinical studies. In essence, adaptive designs allow prospectively planned modifications to a clinical trial based on interim data, provided scientific validity (the ability to draw sound inferences) and data integrity (credibility and reproducibility) are preserved. 

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What Drives Clinical Trial Quality Today?

October 18, 2017

Explore What We Learned at the 8th Clinical Quality Oversight Forum 

Veristat’s Senior Director of Corporate Compliance attended the 8th Clinical Quality Oversight Forum, an annual conference which took place 10-13 October 2017 in Philadelphia, PA.   

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