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Regulatory Sciences Blog Posts

September 22, 2021 Regulatory Sciences

How to Present Scientific Data That Generates Regulatory Approvals

The best path to regulatory success for your drug's development is to…

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September 16, 2021 Regulatory Sciences

Have an FDA Submission on Your 2021 To-Do List?

You Might Still Have Time to Check it Off…

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August 6, 2021 Regulatory Sciences

Meet the Expert: Marla Scarola

Our “Meet the Expert” series introduces you to our team of experts…

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July 28, 2021 Regulatory Sciences

Understanding The Medical Device Single Audit Program

Your guide to understanding the Medical Device Single Audit Program (MDSAP), including…

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July 22, 2021 Regulatory Sciences

The Human Factor – Preparing Your Device for Usability Testing

Usability studies that take the "human factor" into consideration are essential for…

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July 12, 2021 Regulatory Sciences

Pedaling While Fixing a Flat: Conducting a Good FDA Meeting...

Before using a significant risk medical device in a clinical study, Sponsors…

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July 1, 2021 Regulatory Sciences

Former Deputy Director of Diagnostics, Bill and Melinda Gates Foundation,...

Dr. Giachetti’s extensive experience managing complex diagnostics programs make her a valuable…

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June 28, 2021 Regulatory Sciences

45 Years of 510(k) Submissions: FDA Celebrates with Improvements to...

FDA is working to bring life-saving devices to market as quickly as…

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