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FDA has issued a Draft Guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities”. Comments may be made to Docket number FDA-2023-D-4416 by 26 December 2023. This draft guidance describes how the FDA will request and conduct voluntary remote interactive evaluations of drug facilities.

The guidance describes the various remote interactive tools the agency has developed.  Any combination of these tools will be considered a ‘remote interactive evaluation’. This policy applies to all drug inspection programs, but use of an RIE will be solely at the discretion of the agency. Companies may not request an RIE. There are numerous factors that must be weighed by the agency in determining if an RIE would be appropriate for the given evaluation.

The FDA will contact any facility it identifies as a candidate for an RIE and request the facility’s cooperation. If the facility agrees to be evaluated remotely, the agency will schedule a brief virtual planning meeting. Full details can be found in the draft guidance.

Remember EAS is here to assist and support our clients through any type of FDA evaluation/inspection if needed. Please contact Lisa El-Shall, Sr. Director Pharmaceutical & Device Consulting Services for information on GMP support.

Posted in FDA and USDA Regulatory Update.