Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

Posted by Joshua Walonoski on Posted on

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Not surprisingly, investors highly scrutinize these proceedings and stock markets react accordingly. For these reasons, it is critical for
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4 Problems Importing Rapid Antibody Tests for Coronavirus

Posted by Joshua Walonoski on Posted on

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. However, applying for a COVID-19 EUA Letter from FDA is
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FDA requirements for coronavirus tests with at-home specimen collection

Posted by Joshua Walonoski on Posted on

Although FDA continues to streamline its process to submit a package requesting an Emergency Use Authorization (EUA) letter for SARS-CoV-2 diagnostic tests, it can be challenging and the precise nature of the submission must be followed.
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How to apply for an FDA Coronavirus Emergency Use Authorization Letter

Posted by Joshua Walonoski on Posted on

Applying for a COVID-19 Emergency Use Authorization (EUA) Letter from FDA is no small feat, even though FDA has tried to simplify the process.
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