What You Need to Know About FDA Oversight of Genomics Research

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Last Posted: Nov 20, 2017

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• What You Need to Know About FDA Oversight of Genomics Research  
  C Wagner, NHGRI, Nov 18. 2017
• Committee Opinion No. 724 Summary: Consumer Testing for Disease Risk.  
  et al. Obstetrics and gynecology 2017 Nov 130(5) 1176-1177
• The Dangers of Direct-to-Consumer Genetic Testing for Alzheimer's Disease : Comment on "Personal Genomic Testing, Genetic Inheritance, and Uncertainty".  
  Lacaze Paul et al. Journal of bioethical inquiry 2017 Nov
• Committee Opinion No. 724: Consumer Testing for Disease Risk.  
  et al. Obstetrics and gynecology 2017 130(5) e270-e273
• A Window Into Clinical Next-Generation Sequencing-Based Oncology Testing Practices.  
  Nagarajan Rakesh et al. Archives of pathology & laboratory medicine 2017 Oct
• Navigating social and ethical challenges of biobanking for human microbiome research.  
  Chuong Kim H et al. BMC medical ethics 2017 Jan 18(1) 1
• Comparative preimplantation genetic diagnosis policy in Europe and the USA and its implications for reproductive tourism.  
  Bayefsky Michelle J et al. Reproductive biomedicine & society online 2016 Dec 341-47
• Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium.  
  Wolf Susan M et al. Genetics in medicine : official journal of the American College of Medical Genetics 2017 Aug
• Oversight of Genomic Data Sharing: What Roles for Ethics and Data Access Committees?  
  Shabani Mahsa et al. Biopreservation and biobanking 2017 Aug
• Biomarker Tests for Molecularly Targeted Therapies: Laying the Foundation and Fulfilling the Dream.  
  Lyman Gary H et al. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2016 Jun 34(17) 2061-6
• Open sharing of genomic data: Who does it and why?  
  Haeusermann Tobias et al. PloS one 2017 12(5) e0177158
• Community recommendations on biobank governance: Results from a deliberative community engagement in California.  
  Dry Sarah M et al. PloS one 2017 12(2) e0172582
• Insights from early experience of a Rare Disease Genomic Medicine Multidisciplinary Team: a qualitative study.  
  Ormondroyd Elizabeth et al. European journal of human genetics : EJHG 2017 Mar
• Using lessons from breast, cervical, and colorectal cancer screening to inform the development of lung cancer screening programs.  
  Armstrong Katrina et al. Cancer 2016 122(9) 1338-42
• Health and genetic ancestry testing: time to bridge the gap.  
  Smart Andrew et al. BMC medical genomics 2017 Jan 10(1) 3
• Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process.  
  Murdoch Blake et al. Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC 2017 Jan 39(1) 10-17

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