ArticleClinical and translational science2020
Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways.
Article in Clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- Article
- Post-Marketing Requirements for Anticancer Drugs Approved in Japan, 2001-2024: A Cross-Sectional Analysis.CPT: pharmacometrics & systems pharmacology · 2026Article
- Expedited regulatory approval pathways for novel oncology drugs.Medical oncology (Northwood, London, England) · 2026Review
- Early and accelerated access programs for medical devices in the European Union: mapping regulatory derogations and national schemes.Frontiers in medical technology · 2026Review
- Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval.Therapeutic innovation & regulatory science · 2025Article
- Financing drug development via adaptive platform trials.PloS one · 2025Article
- Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.The European journal of health economics : HEPAC : health economics in prevention and care · 2024Review
- Next generation microfluidics: fulfilling the promise of lab-on-a-chip technologies.Lab on a chip · 2024Review
- Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.Therapeutic innovation & regulatory science · 2023Article
- Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.Clinical and translational science · 2023Article
- A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.Clinical and translational science · 2022Article
- A Primer on RECIST 1.1 for Oncologic Imaging in Clinical Drug Trials.Radiology. Imaging cancer · 2021Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Developing a novel drug, including discovery, nonclinical toxicology studies, initial clinical trials, and thorough pivotal studies, may take many years. Once an applicant has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the marketing authorization application. Review by regulatory authorities to evaluate whether the data support a positive benefit/risk profile takes many months, adding additional time before patients may access therapy. In this paper, we discuss the various opportunities the US Food and Drug Administration and the European Medicines Agency offer to expedite the drug development and regulatory approval timelines for drugs intended to treat serious diseases and unmet medical needs.
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.