ArticleClinical and translational science2019
Regulatory Affairs 101: Introduction to Investigational New Drug Applications and Clinical Trial Applications.
Article in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed.
- Impact of a Research Integrity Assessment (RIA) of Randomized Controlled Trials Included in Interventional COVID-19 Systematic Reviews: A Meta-Epidemiological Study.Cochrane evidence synthesis and methods · 2026Article
- Approved and Pipeline Pharmacological Interventions for Eating Disorders (2010-2025): 15 Years of Progress (or Lack Thereof).CNS drugs · 2026Review
- Centralized daily drug management in clinical trial institutions and specific implementation plans.Frontiers in drug safety and regulation · 2025Review
- Aspects and prospects of preclinical theranostic radiopharmaceutical development.Theranostics · 2024Review
- Swine models for translational oncological research: an evolving landscape and regulatory considerations.Mammalian genome : official journal of the International Mammalian Genome Society · 2022Review
- In vitro tools for orally inhaled drug products-state of the art for their application in pharmaceutical research and industry and regulatory challenges.In vitro models · 2022Review
- Regulation of Molecular Farming Products.Methods in molecular biology (Clifton, N.J.) · 2022Article
- The Emergency Response Capacity of Plant-Based Biopharmaceutical Manufacturing-What It Is and What It Could Be.Frontiers in plant science · 2020Review
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
Testing novel drugs on fellow human beings is fraught with potential ethical concerns; however, developing drugs to treat the wide spectrum of human diseases and disorders is a moral imperative. How do we best navigate the balance between protecting the individual vs. the greater good? Global government regulatory bodies are accountable for ensuring that medical experiments on human subjects are appropriately justified and subject to close oversight. In this article, we focus on two major global health authorities, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and the path to legally treating humans with new investigational products.
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.