Discover Community Create You

Loading publication...

Noodle always counts identifier-free feature events for service operation. With your permission, Google Analytics can also estimate audience and engagement. Search text, publication identifiers, cookies, IP addresses and browser fingerprints are never included in Noodle's first-party event counters.

Privacy details

Article

Development of Cell and Gene Therapies for Clinical Use in the US and EU: Summary of Regulatory Guidelines

27 Apr 2024

Abstract excerpt

Recent decades have seen advancements in the management and treatment of difficultto- treat diseases such as cancer. A special class of therapeutics called cell and gene therapy has been introduced in the past 10 years. Cell and gene therapy products have strengthened the treatment options for life-threatening diseases with unmet clinical needs and also provided the possibility of a potential cure for the disease...

Read the complete abstract on PubMed

Topics

Share this publication in a Topic to start or enrich a Post.

Share to Biomedical Ethics and Regulation
Share to CAR-T cell therapy research
Share to CRISPR and Genetic Engineering

Methodology Data sources Editorial policy Privacy About Contact Helena Bioinformatics

Source

Identifiers

PMID: 38676481
DOI: 10.2174/0115665232306205240419091414

Provenance

PubMed metadata and Literature Corpus relationships. Corpus snapshot updated 7 Sept 2026.

Related research

Semantic proximity does not establish scientific evidence.

Research trail→

Click a neighbor to travelStep 1 · 12 closest

Development of Cell and Gene Therapies for Clinical Use in the US and EU: Summary of Regulatory GuidelinesPMID 38676481Read ↗

Challenges and Pathways in Regulating Next-Gen Biological TherapiesSemantic proximity Read ↗

Clinical development of gene- and cell-based therapies: overview of the European landscapeSemantic proximity Read ↗

A few ethical issues in translational research for gene and cell therapySemantic proximity Read ↗

Considerations for Cell and Gene Therapy Programs Entering the Clinical SpaceSemantic proximity Read ↗

Development and Clinical Translation of Approved Gene Therapy Products for Genetic DisordersSemantic proximity Read ↗

Gene therapies development: slow progress and promising prospectSemantic proximity Read ↗

An International Society for Cell & Gene Therapy working group short report on the future of expanded access to unapproved cell and gene therapiesSemantic proximity Read ↗

BJCP-EMA commentaries on the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.Semantic proximity Read ↗

Advances and Challenges in the Development of Gene Therapy Medicinal Products for Rare DiseasesSemantic proximity Read ↗

Considerations for manufacturing of cell and gene medicines for clinical developmentSemantic proximity Read ↗

Scientific and Regulatory Policy Committee Points to Consider: Nonclinical Research and Development of In Vivo Gene Therapy Products, Emphasizing Adeno-Associated Virus VectorsSemantic proximity Read ↗

EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cellsSemantic proximity Read ↗

⌁Select a neighboring publication to make it the new centre.