The Next Phase of Human Gene-Therapy Oversight

As gene therapy continues to change, so must the federal framework set up to oversee it. As new biotechnologies continue to emerge, the NIH and the FDA are proposing reductions in duplicative oversight and changes to the role of the Recombinant DNA Advisory Committee.

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Bibliographic Details
Published inThe New England journal of medicine Vol. 379; no. 15; pp. 1393 - 1395
Main Authors Collins, Francis S, Gottlieb, Scott
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 11.10.2018
Subjects
Annual reports
Clinical trials
Clinical Trials as Topic
CRISPR
Databases, Factual
Deoxyribonucleic acid
DNA
FDA approval
Gene Editing
Gene therapy
Genetic Therapy - history
Genetic Therapy - legislation & jurisprudence
Genomes
Government Regulation - history
Guidelines as Topic
History, 20th Century
History, 21st Century
Humans
National Institutes of Health (U.S.)
Recombinant DNA
United States
United States Food and Drug Administration
United States > US
Maryland
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Summary:As gene therapy continues to change, so must the federal framework set up to oversee it. As new biotechnologies continue to emerge, the NIH and the FDA are proposing reductions in duplicative oversight and changes to the role of the Recombinant DNA Advisory Committee.
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SourceType-Scholarly Journals-1
ObjectType-Feature-2
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ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMp1810628