ArticleJACC. Basic to translational science2016
Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs.
Article in JACC. Basic to translational science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 159 papers, 2 of them syntheses 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
159 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.Journal of medical Internet research · 2020Pooled it
- Validation of Progression-Free Survival Rate at 6 Months and Objective Response for Estimating Overall Survival in Immune Checkpoint Inhibitor Trials: A Systematic Review and Meta-analysis.JAMA network open · 2020Pooled it
- Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir.Antimicrobial agents and chemotherapy · 2025Trial
- A staged zebrafish-mouse screening strategy for antiseizure compound prioritization.Neuropharmacology · 2026Article
- CRISPR in clinical oncology: translational advances from molecular diagnostics to therapeutics.Nature reviews. Clinical oncology · 2026Review
- Making the Case for Organ-on-Chip Platforms in Long-Acting Therapeutics Development.Advanced healthcare materials · 2026Review
- Integrating Structured Expert Elicitation with External Evidence to Inform Earlier Reimbursement Decisions: A Norwegian Case Study of Selpercatinib for Non-Small Cell Lung Cancer.PharmacoEconomics - open · 2026Article
- Artificial intelligence in drug research and development: a review of methods and applications in drug repurposing.Briefings in bioinformatics · 2026Review
- Computational discovery of marine natural phytochemicals as novel SIRT7 inhibitors for cancer treatment.Journal, genetic engineering & biotechnology · 2026Article
- Introduction to animal modelling: factors and tools for choosing the optimal model for sarcoma research-a comprehensive literature review.Translational cancer research · 2026Review
- Enzyme therapy as a promising strategy to overcome multi-drug resistance in pathogens: current advances, key challenges, and future directions.RSC advances · 2026Review
- Concerns and challenges in clinics-guided nanovaccines design and applications.Acta pharmaceutica Sinica. B · 2026Review
- Microbial contamination of medicines, medical devices, cosmetics, child and personal care products: a comprehensive review of secondary contamination risks in home-use settings.Frontiers in microbiology · 2026Review
- SIRT7 as a context-dependent biomarker and therapeutic target: Insights from a pan-cancer study.PloS one · 2026Article
- Driving precision medicine in testicular germ cell tumors: from preclinical models to clinical applications.Therapeutic advances in medical oncology · 2026Review
- Repurposing clinically safe drugs for DNA repair pathway choice in CRISPR genome editing and synthetic lethality.Nature communications · 2025Article
- The future of phage therapy in the USA.Trends in molecular medicine · 2025Review
- 3D Bioprinting and Artificial Intelligence for Tumor Microenvironment Modeling: A Scoping Review of Models, Methods, and Integration Pathways.Molecular pharmaceutics · 2025Article
- Real-World Evidence in FDA Approvals for Labeling Expansion of Small Molecules and Biologics.Therapeutic innovation & regulatory science · 2025Review
- Advancing ADMET prediction through multiscale fragment-aware pretraining with MSformer-ADMET.Briefings in bioinformatics · 2025Article
99 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world. Its mission includes ensuring that new medical treatments reach the public as quickly as possible while simultaneously ensuring that new treatments are both safe and effective. In the face of urgent consumer need, the FDA has faced criticism that its processes are too lengthy and costly and that the time to new drug release is significantly longer in the United States than in other Western countries. Calls from the public to loosen FDA regulations to facilitate more rapid approval of drugs and devices have been countered by the occurrence of patient harm and deaths after some approved drugs have reached the marketplace. New drug and device approval in the United States take an average of 12 and 7 years, respectively, from pre-clinical testing to approval. Costs for development of medical devices run into millions of dollars, and a recent study suggests that the entire cost for a new drug is in excess of $1 billion. For investigators seeking approval for new drugs and devices, FDA processes can be formidable. This 2-part series is intended to provide an overview of the steps involved in bringing new drugs and devices through the FDA process. Part 1 concerns the process of new drug approvals. Part 2 continues with approval of medical devices.
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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.