ArticleTherapeutic innovation & regulatory science2025
A 7-Year Analysis of the U.S. FDA Good Clinical Practice Inspection Outcomes for Marketing Applications.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Analyses of U.S. FDA GCP Assessments and Recommendations for Marketing Applications, 2015-2024.Therapeutic innovation & regulatory science · 2026Article
- Lessons and Insights from a Case Study on Clinical Trial Fraud.Therapeutic innovation & regulatory science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe U.S. Food and Drug Administration (FDA) conducts Good Clinical Practice (GCP) inspections to support regulatory decisions on marketing applications. Inspection outcomes including issuance of Form FDA 483 and a comparison of recommended and final inspection classifications have never been reported.
methodsGCP inspections conducted from calendar year 2017 to 2023 were analyzed by characteristics and outcomes. The recommended and final inspection classifications were compared to determine no change, upgrades, or downgrades. The inspection deficiency areas for upgrades and downgrades were summarized.
resultsThe FDA completed 2836 review-based routine GCP inspections in support of Center for Drug Evaluation and Research (CDER) marketing applications between 2017 and 2023. Overall, final no action indicated (NAI), voluntary action indicated (VAI), and official action indicated (OAI) classifications were determined for 81.2%, 18.5%, and 0.3% of all inspections (The majority of final OAI classifications are driven by for-cause GCP inspections rather than review-based GCP inspections). The percent of establishments issued a Form FDA 483 decreased from 2017 (23.5%) to 2023 (10.4%). Roughly 97% of recommended NAI and 96% of recommended VAI classifications received the same final classification, but there was an increase of VAI to NAI downgrades during years 2020 to 2022. Common deficiency areas related to both upgrades and downgrades were adherence to trial protocol and adequacy of records.
conclusionsNearly all (99.7%) inspections were classified as either NAI or VAI during the study period, and their recommended and final classifications remained highly congruent. The Coronavirus Disease 19 (COVID-19) pandemic likely impacted the number of VAI to NAI downgrades.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.