WASHINGTON, June 26 -- Food and Drug Administration has issued a notice called: Conducting Remote Regulatory Assessments-Questions and Answers; Guidance for Industry; Availability.
The notice was published in the Federal Register on June 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Conducting Remote Regulatory Assessments-Question and Answers." The final guidance describes FDA's current thinking regarding its use of remote regulatory assessments (RRAs) and provides answers to frequently asked questions. FDA has used RRAs to conduct oversight, mitigate risk, me...