ArticleBMJ (Clinical research ed.)2017
Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.
Article in BMJ (Clinical research ed.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis that pooled 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.
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
46 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Longitudinal changes in the relative toxicity of FDA-approved oncology therapeutics: evidence from paired initial and updated RCT reports.Frontiers in public health · 2026Pooled it
- Timing between public safety signals and label strengthening in targeted oncology therapies.European journal of clinical pharmacology · 2026Article
- Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics.Clinical pharmacology and therapeutics · 2026Article
- Article
- Postmarket Safety Actions for Novel Oncology Drugs Granted FDA's Accelerated Approval.JAMA network open · 2026Article
- Disparities in access to systemic therapies for patients with hepatocellular carcinoma: an analysis from the International Liver Cancer Association.The Lancet regional health. Europe · 2025Review
- Era of surrogate endpoints and accelerated approvals: a comprehensive review on applicability, uncertainties, and challenges from regulatory, payer, and patient perspectives.European journal of clinical pharmacology · 2025Review
- Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices.Medical decision making : an international journal of the Society for Medical Decision Making · 2025Article
- The UK's Early Access to Medicines Scheme 10 years on: an evaluation using publicly available data.JRSM open · 2025Article
- Putting the substance in substantial evidence: an evidence-based approach to flexible drug regulation.Frontiers in medicine · 2025Article
- Navigating Recent Changes in Dosing Information: Dynamics of FDA-Approved Monoclonal Antibodies in Post-Marketing Realities.Clinical and translational science · 2025Review
- Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling.Drug safety · 2024Article
- Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.Clinical and translational science · 2024Article
- Article
- Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma.Nature reviews. Clinical oncology · 2024Article
- Observational
- Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.Journal of general internal medicine · 2022Article
- Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021.JAMA network open · 2022Article
- Post-Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004-2014.Clinical pharmacology and therapeutics · 2022Article
- Pharmacists' Knowledge and Perceptions of FDA Approval Standards and the Breakthrough Therapy Designation.Pharmacy (Basel, Switzerland) · 2022Article
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
PubMed holds no abstract for this paper.
Indexed as
Identifiers
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.