Conducting Remote Regulatory Assessments-Questions and Answers; Guidance for Industry; Availability

Streszczenie

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, meet critical public health needs, and help evaluate compliance of FDA- regulated products with applicable regulatory requirements.