Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program." This guidance provides premarket approval application (PMA) applicants with information about the bioresearch monitoring (BIMO) review process. This includes a BIMO evaluation of clinical and nonclinical information in the PMA and certain PMA supplements as well as preapproval BIMO inspections. The procedural information outlined in this document should help applicants and FDA to better understand the BIMO review and inspection so it can proceed in a timely manner.