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Pandemic Alters FDA Inspections and Quality Oversight

November 1, 2021


Over the past 18 months, FDA officials have tested and adopted a range of procedures to overcome restrictions on visiting facilities in person to evaluate pharmaceutical production and clinical testing operations. Many of these alternative compliance methods now are being retained even with the end of the current health emergency in sight. FDA has devised ways to monitor industry operations and to collaborate more routinely with foreign regulatory authorities to assess facilities and products, efforts important for ensuring continued patient access to needed therapies, vaccines, and medical diagnostics.

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