FDA Releases COVID-19 Vaccine Guidance for IndustryJuly 8, 2020
On June 30, 2020 the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research released its first “Guidance for Industry” document for the development and licensure of COVID-19 vaccines. The full text of the Guidance is available here. While the procedures and recommendations set forth in the Guidance are nonbinding and subject to change, the document nevertheless provides interested stakeholders with a comprehensive overview of FDA’s current thinking on what benchmarks will need to be met before a COVID-19 vaccine is approved for widespread use.
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