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July 7, 2020  •  Blog

FDA issues COVID-19 Vaccine Guidance

On June 30, 2020 FDA issued a new guidance on Development and Licensure of Vaccines to Prevent COVID-19. The guidance sets regulatory expectations for the manufacture, non-clinical, clinical and post-licensure use of the vaccine(s). While the agency is cognizant of the urgent need for a COVID-19 vaccine…

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May 30, 2020  •  Blog

New Policy for SARS–CoV–2 Serology Tests

FDA significantly tightened oversight on SARS‐COV‐2 serology tests by publishing new policy requiring all serology tests to be reviewed and approved under Emergency Use Authorization (EUA). In a rush to make serology antibody tests available as quickly as possible, FDA previously allowed SARSCOV‐ 2…

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