Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations." This guidance document explains for premarket approval application (PMA) applicants the process involved with the review of a PMA manufacturing section and inspection of the manufacturing operations described in the manufacturing section. This guidance is also generally applicable to the process involved with the review of manufacturing information in certain PMA supplements. The procedural information outlined in this document should help applicants and FDA schedule and complete their work in a timely manner.