ArticleScientific reports2024
Analysis of US Food and Drug Administration new drug and biologic approvals, regulatory pathways, and review times, 1980-2022.
Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed.
- Innovative strategies for early detection of cardiotoxicity: artificial intelligence and multi-modality collaborative models.Journal of thrombosis and thrombolysis · 2026Review
- Development Timelines of Innovative Drugs in China: A 15-Year Cross-Sectional Analysis of Characteristics and Influencing Factors.Clinical and translational science · 2026Article
- Online interest in calcitonin gene-related peptide-therapies: An infodemiology study using Google trends.Headache · 2026Article
- International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets.EClinicalMedicine · 2026Article
- Recombinant Protein Drugs: A 2025 Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Reimagining pharmacology education.Pharmacological reviews · 2026Review
- Evidentiary Standards for Newly Approved Antibiotics for Uncomplicated Urinary Tract Infections.Antibiotics (Basel, Switzerland) · 2026Article
- Regulatory approval, reimbursement and postmarketing evidence of class 1 novel drugs in China, 2018-2023: an observational study.BMJ public health · 2026Article
- Comparison of Food and Drug Administration expedited approvals and guideline updates: A case study of immune checkpoint inhibitors in colon cancer care.Cancer letters · 2025Article
- A generalizable deep learning framework for structure-based protein-ligand affinity ranking.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Target agnostic cellular screening in the era of chemically induced proximity.RSC medicinal chemistry · 2025Review
- The New Paradigm in Pharma R&D.ACS medicinal chemistry letters · 2025Article
- Cell and tissue reprogramming: Unlocking a new era in medical drug discovery.Pharmacological reviews · 2025Review
- Current landscape of US Food and Drug Administration use of expedited regulatory approvals for colorectal cancer care.Journal of managed care & specialty pharmacy · 2025Article
- Developing, Analyzing, and Interpreting Outcome Assessments to Improve Endpoints in Infectious Diseases Clinical Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Testing the knowledge of artificial intelligence chatbots in pharmacology: examples of two groups of drugs.PeerJ. Computer science · 2025Article
- A Comprehensive Review of the Diversity of Fungal Secondary Metabolites and Their Emerging Applications in Healthcare and Environment.Mycobiology · 2024Review
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
Abstract
U.S. laws enacted since 1983 have aimed to enhance the development and marketing of new pharmaceutical products. We thoroughly characterized all new molecular entities, therapeutic biologics, and gene and cell therapies approved by the US Food and Drug Administration (FDA) during the period 1980-2022 in the context of these laws and regulations. Throughout the study period, the FDA approved 1355 new pharmaceutical products. The median FDA review time decreased from 26.6 months prior to the Prescription Drug User Fee Act (1992), which authorized the FDA to collect fees from drug companies to 9.9 months after the Food and Drug Administration Safety and Innovation Act (2012), which created new designations that eliminated the requirement for evidence of added therapeutic benefit for FDA expedited drug review. The greatest increase in approvals occurred in antineoplastic and immunomodulating drugs, biologics, and orphan drugs. More than half of new drug approvals benefited from regulatory designations and pathways that did not require addressing unmet medical needs or demonstrating therapeutic benefit over available alternatives. The legislative goal of bringing more drugs to the market faster has been achieved. Further studies are needed to determine the therapeutic value to patients of new drugs approved using expedited approval pathways.
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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.