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New Draft Guidance on Remote Regulatory Assessments


  • On July 22, the FDA published a draft guidance on conducting Remote Regulatory Assessments. Remote Regulatory Assessments (RRAs) were originally developed during the COVID-19 health emergency and are a set of tools to help the Agency conduct oversight, mitigate risk, and meet critical public health needs with respect to certain FDA-regulated products.
  • Currently, requests for records or other information from drug establishments under section 704(a)(4) of the FD&C Act, and requests for FSVP records under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), are RRAs that FDA conducts for which participation is mandatory. RRAs that are not conducted under statutory or regulatory authority are voluntary, meaning that an establishment can decline to participate, in which case the Agency would consider other tools for evaluating compliance with FDA requirements.
  • The draft guidance describes the FDA’s current thinking on its use of RRAs and is intended to increase the industry’s understanding of RRAs and the FDA’s process for conducting RRAs. The draft guidance provides answers to frequently asked questions about what RRAs are, when and why FDA may use them, and how they are conducted, among other FAQs.
  • Stakeholders may submit comments on the draft guidance until September 23. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.


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