Analyses of U.S. FDA GCP Assessments and Recommendations for Marketing Applications, 2015-2024.

Courtney McGuire, Michelle Foringer, David Burrow, Jenn Sellers, Cheryl Grandinetti, Kassa Ayalew

Abstract read

In one paragraph

Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Courtney McGuireOffice of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, WO51, MD, 20993, Silver Spring, USA. courtney.mcguire@fda.hhs.gov.

Michelle ForingerOffice of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, WO51, MD, 20993, Silver Spring, USA.

David BurrowOffice of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, WO51, MD, 20993, Silver Spring, USA.

Jenn SellersOffice of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, WO51, MD, 20993, Silver Spring, USA.

Cheryl GrandinettiOffice of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, WO51, MD, 20993, Silver Spring, USA.

Kassa AyalewOffice of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, WO51, MD, 20993, Silver Spring, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe U.S. Food and Drug Administration conducts Good Clinical Practice (GCP) assessments and provides recommendations through Clinical Inspection Summary (CIS) reports to inform marketing application reviews. Despite their integral role in regulatory oversight, the characteristics of GCP assessments and recommendations have not been comprehensively evaluated.

methodsThis 10-year retrospective descriptive study analyzed CIS reports supporting marketing applications from 2015 to 2024. Data were extracted from FDA internal databases and analyzed. CIS reports were categorized into Tier 1-3, a framework developed by the authors for this study. In Tiers 1 and 2, data were recommended as acceptable to support the marketing application. In Tier 3, specific actions were recommended to address data quality issues.

resultsThe analysis included 1,200 CIS reports supporting regulatory review of predominantly New Drug Applications (69.9%) and Biologics License Applications (29.9%), with 68.0% supporting original submissions. The most frequent recommendation tier was Tier 1 (69.5%), followed by Tier 3 (22.5%), and Tier 2 (8.0%). Within Tier 3, most CIS reports contained a single type of recommended action (66.7%), and the most common recommended actions involved requesting additional information (32.8%), conducting additional statistical analyses (28.3%), and incorporating updated data (24.8%).

conclusionsGCP oversight largely supported data acceptability for marketing applications, with specific actions recommended to address data quality issues, underscoring its critical role in ensuring reliable clinical data.

Indexed as

Clinical Trials as TopicDrug ApprovalUnited States Food and Drug AdministrationDecision Making, OrganizationalRetrospective StudiesUnited StatesGood clinical practice (GCP) assessmentInspectionRecommendationU.S. Food and Drug Administration (FDA)

Identifiers

PMID42062756

DOI10.47912/jscdm.216

What OpenQuestion holds

Textmetadata

Read underepoch 390

Registered trials

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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.