ARTICLE SUMMARY:
FDA advocates for continuing remote regulatory assessments post-pandemic. Excerpted from Pathways' Picks July 27: Pink Slips? Remote Assessments, and Next EU Expert Panel.
FDA wants to continue to rely on remote record assessments and virtual interviews to fill in information gaps on companies post-pandemic. It issued a draft guidance July 22 to lay out procedures for doing so. “FDA has noted the value of RRAs [Remote Regulatory Assessments] and concluded that they should be used for certain scenarios outside the current pandemic and for all types of FDA-regulated products,” the draft states. The agency launched a voluntary RRA program for devices in February 2021. The program will continue to be voluntary for devices under the draft guidance, but the document makes clear that a company deciding to decline an FDA RRA request risks getting an onsite inspection more quickly or a slowdown in another regulatory process that depends on the information FDA is seeking. On the plus side, an RRA (which is not, legally, an inspection) could fill in for a pre-approval inspection in some cases, among other benefits, the draft guidance suggests. FDA does have the authority to mandate a remote records assessment for a drug company. And, notably, the Food and Drug Amendments user fee reauthorization bill that passed the House last month includes language that would give FDA that authority for devices. Comments on the draft, which lays out processes and expectations for RRAs, are due September 23.
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