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Policy Issues
Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.
… regulate genetic tests: the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), … clinical validity of most genetic tests. In light of this, FDA has proposed new policies to enhance analytical validity regulation and expand oversight of the clinical validity of …
Educational Resources
Gene regulation is the process of turning genes on and off.
… Gene Regulation … Gene regulation is the process of turning genes on and off. … Gene Expression, Genes, DNA, Transcription Factors … Gene regulation is the process used to control the timing, …
Research Funding
The Genomics of Gene Regulation project develops methods to construct predictive, accurate gene regulatory network models using genomic data​​.
… University of California, Los Angeles "Ribonomics" Of Gene Regulation To Predict Innate Immune Responses … Michael Snyder, Ph.D. Stanford University Genomics Of Gene Regulation In Progenitor To Differentiated Keratinocytes … … Program Staff … Related Content … The Genomics of Gene Regulation (GGR) project develops better methods to construct …
The Genomics Landscape
In the March 2019 edition of The Genomics Landscape, NHGRI Director Eric Green details ClinGen, the first FDA-recognized Public Human Genetic Variant Database.
… … In December 2018, the U.S. Food and Drug Administration (FDA)  announced  that they were recognizing NHGRI's  Clinical … Variant Database guidance. This program is part of an  FDA effort  to provide genetic test developers access to … expert-validated evidence that they can cite when seeking FDA approval of their tests. It is hoped that the …
Staff
Rebecca Hong is a scientific program analyst in the Policy and Program Analysis Branch at the National Human Genome Research Institute. ​
… and project management. The focus areas of her work are FDA regulation of genomic technologies and U.S. science policy … … Rebecca Hong, B.S. … Rebecca Hong, genomic policy, FDA regulation, genomic technology, legislation, AIDS …
News Release
NIH has awarded grants of more than $28 million aimed at deciphering the language of how and when genes are turned on and off.
… awards emanate from the recently launched Genomics of Gene Regulation (GGR) program of the National Human Genome … developing treatments for diseases affected by faulty gene regulation, such as cancer, diabetes and Parkinson's disease. NHGRI launched the Genomics of Gene Regulation (GGR) program to decipher the language of how and …
News Release
NIH investigators have discovered that genomic switches of a blood cell are key to regulating the human immune system.
… to regulating the human immune system. ​ … Immune system regulation, genomic switches in blood cells, autoimmune …
15 Ways Genomics Influences Our World
Advances in genomics are helping you access information about your genome from your home.
… been approved by  the U.S. Food and Drug Administration (FDA) if it is about your health? How will you handle the … Testing, Regulations, Food And Drug Administration (FDA) … Advances in genomics are helping you access …
Fact Sheet
Several regulations and policies stipulate the information that must be given to research participants prior to their enrolling in a study.
… biospecimens."   Food and Drug Administration (FDA) regulations require informed consent for both private … biological products and devices. When the Common Rule regulation was revised in 2018 , it introduced a number of differences between the Common Rule and FDA’s regulations and requirements regarding informed …
News Release
The U.S. National Institutes of Health (NIH) has long invested in basic genetics and genomics research, clinical trials, as well as translational medicine and social science studies, to advance our understanding of this widespread illness to help develop effective therapies.
… Today, the U.S. Food and Drug Administration (FDA) approved two gene therapies for the treatment of sickle … (NHLBI)   … Additional Resources … NIH statement on new FDA-approved gene therapies for sickle cell disease … The …