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Home » New FDORA Provision Allows FDA to Conduct Some Inspections Based on Records Review
New FDORA Provision Allows FDA to Conduct Some Inspections Based on Records Review
In a potentially “game-changing” legislative move, the Food and Drug Omnibus Reform Act of 2022 (FDORA) has given the FDA the option to rely on review of records and other information collected from a manufacturer in lieu of some types of on-site inspections.