Article

FDA oversight of NSIGHT genomic research: the need for an integrated systems approach to regulation

2019-07-30

Abstract excerpt

<h4>ABSTRACT</h4> The National Institutes of Health (NIH) funded the N ewborn S equencing I n G enomic medicine and public H eal T h (NSIGHT) Consortium to investigate the implications, challenges and opportunities associated with the possible use of genomic sequence information in the newborn period. Following announcement of the NSIGHT awardees in 2013, the Food and Drug Administration (FDA) contacted investigat...

Topics

Open a Topic to create a Post that cites this publication.

Identifiers and source

Literature Corpus work: 4c130e6e-943c-5e87-bb1b-9e9890f9a19a
DOI: 10.1101/19001370

Open publication

Related research

Semantic proximity does not establish scientific evidence.

Click a neighbor to travelStep 1 · 12 closest

FDA oversight of NSIGHT genomic research: the need for an integrated systems approach to regulationDOI 10.1101/19001370Read

Reflections on the US FDA's Warning on Direct-to-Consumer Genetic TestingSemantic proximity Read

Whole genome sequencing as an investigational device for return of hereditary disease risk and pharmacogenomic results as part of the <i>All of Us</i> Research ProgramSemantic proximity Read

Optimizing regulatory frameworks for gene therapies in rare diseases: Challenges and solutionsSemantic proximity Read

Toward Better Oversight of NGS Tests.Semantic proximity Read

Analysis of state laws on informed consent for clinical genetic testing in the era of genomic sequencing.Semantic proximity Read

A primer on regulation of laboratory-developed testing procedures: A points to consider statement of the American College of Medical Genetics and Genomics (ACMG)Semantic proximity Read

Charting the Ethical Frontier in Newborn Screening: Insights from the NBSTRN ELSI Researcher Needs SurveySemantic proximity Read

Regulation of Next Generation SequencingSemantic proximity Read

The Next Phase of Human Gene-Therapy OversightSemantic proximity Read

Innovation, risk, and patient empowerment: the FDA-mandated withdrawal of 23andMe's Personal Genome Service.Semantic proximity Read

Long-term follow-up after authorization of gene therapy: leveraging real-world dataSemantic proximity Read

Who Should Regulate Preimplantation Genetic Diagnosis in the United States?Semantic proximity Read