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FDA Provides Guidance on Remote Facility Evaluations

November 1, 2023


FDA released a draft guidance on Oct. 25, 2023 explaining the agency’s procedures for how it requests and conducts voluntary remote interactive evaluations at drug manufacturing facilities and facilities that operate under FDA’s Bioresearch Monitoring (BIMO) program. According to the guidance document, the agency may decide to perform remote interactive evaluations based on mission needs and travel limitations. These types of evaluations may be conducted for preapproval inspections; prelicense inspections; postapproval inspections; surveillance inspections; follow-up and compliance inspections; and BIMO inspections.

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