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Regulatory/FDA

Omicron Causes FDA Suspension of Most U.S. Inspections Through Jan. 19

Omicron Causes FDA Suspension of Most U.S. Inspections Through Jan. 19

Jan. 10, 2022 – The Food and Drug Administration’s (FDA’s) ability to catch up with its inspection backlog caused by the COVID-19 pandemic is slowing again after the FDA temporarily postponed many inspectional activities in the United States through Jan. 19 and deferred foreign inspection assignments that were slated for February 2022. According to an […]

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Regulatory/FDA

FDA Reportedly Preparing Guidelines for Omicron-targeted Vaccine Studies

FDA Reportedly Preparing Guidelines for Omicron-targeted Vaccine Studies

Dec. 6, 2021 – As the seemingly fast-spreading COVID-19 omicron variant begins to show up in the United States, the Food and Drug Administration (FDA) is taking measures now to meet any potential need for new diagnostics, vaccines and therapeutics to combat the next phase of the pandemic. On Dec. 2, President Joe Biden announced […]

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