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Greg Levine Navigates Coronavirus Lab Test Developer Through Novel FDA Process

Practices: Life Sciences, FDA Regulatory, Health Care, Digital Health, Clinical Research, Technology, Media & Telecommunications

Capital Insights.

FDA regulatory chair Greg Levine (Washington, D.C.) was profiled in a Law360 article with two other attorneys who are guiding their clients in uncharted legal territory during the growing coronavirus pandemic.

After the U.S. Food and Drug Administration issued new guidance allowing certain laboratories to develop their own tests for COVID-19, Greg was contacted to counsel a client through a new FDA regulatory approval process.

The legal challenges resulted from the FDA permitting certain labs to use coronavirus tests that have been validated in-house before agency approval, something the FDA has never done before.

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