USA – FDA Updates Compliance Guide on Pre-approval Inspections for Drugs

Drug manufacturers looking to avoid Form 483s take note: the US Food and Drug Administration (FDA) has recently tweaked its compliance guide on pre-approval inspections, which according to one consultant will impact analytical procedures and data included in regulatory submissions.

A pre-approval inspection is performed by FDA to ensure that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.

The front of the updated compliance guide, which was first released in September but which will not fully take effect until 16 September 2022, explains the changes: “Revision: Program revised to add instructions for potential official action indicated (pOAI) reporting responsibilities and to align with the Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) agreement Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.”…