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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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Streamline the Medical Writing Process for Simultaneous Submissions

August 6, 2018

By Kimberly Newton, MA, Senior Director Medical Writing

When a team faces multiple submissions in a short timeframe or even simultaneous submissions, uncertainty over timeline organization and the best way to utilize medical writers can be paralyzing.

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Top 10 Operational Tips for Navigating Complex NDA/MAA Submissions

July 27, 2018

by Martha Plaza, MBA, Project Director, Regulatory Submissions

No two New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs) are the same. However, they all have common aspects that create the opportunity for streamlined operational tips. 

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