Evidence map›Paper›PMID 38545329›Full record

ReviewInternational journal of pharmaceutics: X2024

A network of regulatory innovations to improve FDA quality assessments of human drug applications.

Russie Tran, Grace Fraser, Adam C Fisher, Sau L Lee, Ashley Boam, Stelios Tsinontides, Jennifer Maguire, Lawrence X Yu, Susan Rosencrance, Steven Kozlowski and 1 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in International journal of pharmaceutics: X, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

11 authors.

Russie TranFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Grace FraserFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Adam C FisherFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Sau L LeeFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Ashley BoamFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Stelios TsinontidesFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Jennifer MaguireFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Lawrence X YuFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Susan RosencranceFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Steven KozlowskiFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Don HenryFood and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality information in the U.S. This dedicated effort in the FDA's Center for Drug Evaluation and Research (CDER) aims to enhance the quality assessment of submissions for new drugs, generic drugs, and biological products including biosimilars. These regulatory innovations include developing or contributing: (i) the Knowledge-Aided Assessment and Structured Application (KASA), (ii) a new common technical document for quality (ICH M4Q(R2)), (iii) structured data on Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ/CMC), (iv) Integrated Quality Assessment (IQA), (v) the Quality Surveillance Dashboard (QSD), and (vi) the Established Conditions tool from the ICH Q12 guideline. The innovations collectively drive CDER toward a more coordinated, effective, and efficient quality assessment. Improvements are made possible by structured regulatory submissions, a systems approach to quality risk management, and data-driven decisions based on science, risk, and effective knowledge management. The intended result is better availability of quality medicines for U.S. patients.

Indexed as

Knowledge ManagementPharmaceuticalsQuality assessmentsRegulatory innovationsStructured Data

Identifiers

PMID38545329
PMCPMC10966141

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.