ReviewApplied biosafety : journal of the American Biological Safety Association2022
Food and Drug Administration Guidance on Design of Clinical Trials for Gene Therapy Products with Potential for Genome Integration or Genome Editing and Associated Long-Term Follow-Up of Research Subjects.
Review in Applied biosafety : journal of the American Biological Safety Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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
9 citing papers in PubMed.
- AAV-based gene therapies for neovascular AMD.Gene therapy · 2026Review
- NIS-Centered Reporter Gene Imaging and Radionuclide-Integrated Nanoplatforms for Quantitative Tracking of Immune Cell Therapy in Oncology and Inflammatory Disease Models.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Clinical translation of CRISPR-Cas9 therapeutics in cancer and inherited genetic disorders.Frontiers in genome editing · 2026Review
- Risk stratification for future cardiac arrest after COVID-19 vaccination.World journal of cardiology · 2025Review
- The design of retroviral vectors used in the CAR-T products, risk management, and future perspective.MedComm · 2025Article
- A Review of Clinical Trials Involving Genetically Modified Bacteria, Bacteriophages and Their Associated Risk Assessments.Applied biosafety : journal of the American Biological Safety Association · 2024Review
- Cell therapy for neurological disorders.Nature medicine · 2024Review
- A comprehensive literature scoping review of infection prevention and control methods for viral-mediated gene therapies.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2024Article
- Precision medicine in catecholaminergic polymorphic ventricular tachycardia: Recent advances toward personalized care.Annals of pediatric cardiologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: With the burgeoning growth of the gene therapy industry, the Food and Drug Administration (FDA) has produced various guidance documents intended to help gene therapy manufacturers design their preclinical testing and clinical trials to facilitate the process of obtaining marketing approval. Discussion: Biosafety professionals and institutional biosafety committees (IBCs) with oversight of clinical trials or biopharmaceutical manufacturing stand to benefit from understanding how these guidance documents set the standard for writing the clinical research protocols that are reviewed by IBCs. Although the FDA guidance documents are typically meant for manufacturers (either pharmaceutical companies serving as research sponsors or investigators at academic institutions), much of the content is useful for biosafety professionals and IBCs during the IBC review process. Conclusion: This article specifically addresses guidance documents pertaining to gene therapy vectors capable of genomic integration, testing for replication competent retrovirus, genome editing, and long-term follow-up of research subjects.
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.