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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Have an FDA Submission on Your 2021 To-Do List?
You Might Still Have Time to Check it Off…
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Meet the Expert: Marla Scarola
Our “Meet the Expert” series introduces you to our team of experts…
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Understanding The Medical Device Single Audit Program
Your guide to understanding the Medical Device Single Audit Program (MDSAP), including…
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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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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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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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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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