Official Action Indicated Rare in GCP Inspections: Report

FDA researchers say 99.7% of good clinical practice (GCP) inspections conducted from 2017 to 2023 were classified as either NAI (no action indicated) or VAI (voluntary action indicated), and their recommendations and final classifications remained highly congruent. Writing in the open-source Therapeutic Innovation & Regulatory Science, the researchers say the location and type of review-based GCP inspections were fairly consistent from 2017 to 2019, as were the types of applications the inspections supported. After 2019, they say, there was a decline in the number of total and foreign inspections and an increase in the proportion of inspections supporting applications with a priority review designation.

The report says that a notable increase in VAI to NAI downgrades during the Covid-19 pandemic may have been due in part to FDA’s consideration of unavoidable protocol deviations due to the impact of Covid-19 on trial conduct.