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The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.
FDA released a draft guidance on Oct. 25, 2023 explaining the agency’s procedures for how it requests and conducts voluntary remote interactive evaluations at drug manufacturing facilities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.
As part of FDA’s oversight, the agency conducts inspections of FDA-regulated products and manufacturing facilities. The agency may choose to conduct Remote Regulatory Assessments (RRA) before or instead of an onsite facility inspection. “For instance, if a program office determines that an inspection is not necessary, feasible, or practical, FDA may instead conduct an RRA. An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs may consist of (or include) a request to conduct voluntary remote interactive evaluations,” the guidance states. The guidance describes remote interactive tools used to conduct RRA evaluations and refers to use of a combination of these tools as a remote interactive evaluation.
According to the document, FDA will use risk management tools to determine if a facility will be participating in a remote interactive evaluation. However, the agency will not be accepting requests from companies asking FDA to perform a remote interactive evaluation. “Such decisions depend on many factors and information not always known to applicants or facilities, and it would be unduly burdensome on all parties to establish a request-based program,” FDA states in the guidance document.
Facilities will be notified by electronic correspondence or a phone call if they are chosen for a remote interactive evaluation and request the company to confirm willingness to participate in the evaluation. The agency will then work with the company to plan and coordinate evaluation activities. “Declining FDA’s request to perform a remote interactive evaluation could impede our ability to make a timely regulatory decision (e.g., regarding adequacy of a clinical trial used in support of a pending application or adequacy of a drug manufacturing operation described in the application),” the agency states in the guidance.