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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 Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

FDA Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

Sept. 25, 2019 – The traditional position of FDA’s leadership that the importation of foreign medicines is illegal and may pose safety risks to American patients appears to be in conflict with the Trump administration and other politicians who believe importation to be a key element of lowering prescription drug costs. Now, the agency is […]

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