Search Results
Healthcare Provider Genomics Education Resource
An FAQ designed to help healthcare professionals understand the diverse landscape of direct-to-consumer (DTC) genetic testing and the benefits and limitations of these tests.
… Timeline of direct-to-consumer genetic testing (DTC-GT). FDA = Food and Drug Administration; GAO = US Government … at $1,000.  2010:  The Food and Drug Administration (FDA) initiated regulatory proceedings against DTC-GT … to locate the suspect. 7 Additionally, there is little regulation of these services.  Raw-data results still need …
News Release
NIH will award $38.5 million over five years to the Developmental Genotype-Tissue Expression (dGTEx) project, which aims to build a widely available resource of human developmental gene expression in a multitude of tissues for use in basic and clinical research.
News Release
Researchers analyzing human, fly, and worm genomes have found these species have key genomic processes in common, reflecting their shared ancestry.
… Nature , offer insights into embryonic development, gene regulation and other biological processes vital to … how chromatin is organized and how it influences gene regulation in the three species. Using both modENCODE and … a third study, scientists explored similarities in genome regulation. Scientists focused on transcription-regulatory …
Research Funding
The three research domains to be considered for support by the NHGRI Ethical, Legal and Social Implications Research Program.
… Genomics and the Rights of Individuals and Groups Law, Regulation and Policy Governing Genomics Industry, Commerce … examine system-level influences on: the direction and regulation of genomic science, research and technology … Clinical Laboratory Improvement Amendments [CLIA], FDA regulations, EU General Data Protection Regulation …
News Release
NIH will fund researchers to develop computational approaches to figure out which differences in DNA make people more susceptible to disease.
… inherited genetic variants that cause changes in gene regulation associated with cancer. Georgia Institute of …
Clinical Research
The Protocol Service Center provides assistance in the development and administration of study protocols requiring NIH Institutional Review Board approval.
… Assistance with regulatory requirements associated with FDA-regulated research and with compliance with NIH and HHS …
For Patients and Families
​Pharmacogenomics combines the science of how drugs work, called pharmacology, with the science of the human genome, called genomics.​
… called HER2. The U.S. Food and Drug Administration (FDA) also recommends genetic testing before giving the … is adjusted according to the patient's genetic makeup. The FDA also advises doctors to test colon cancer patients for … for using drugs to improve human health. In 2007, the FDA revised the label on the common blood-thinning drug …
Fact Sheet
mRNA vaccines inject cells with instructions to generate a protein that is normally found on the surface of SARS-CoV-2, the virus that causes COVID-19.
… acts like any other mRNA that your cells make. … Yes. The FDA approval process involves careful review of clinical … vaccines? … Can mRNA vaccines change your DNA? … Are FDA-approved mRNA vaccines safe and effective? … How have … in the United States by the Food and Drug Administration (FDA) are mRNA vaccines. … Fact Sheet … Understanding COVID-19 …
Event
On Tuesday, February 6, 2024, the National Human Genome Research Institute hosted an eConsult webinar to provide an overview of three notice of funding opportunities (RFA-HG-24-001, PAR-24-106 and PAR-24-107). Questions were answered during the webinar.
… : PHS 2023-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications … : PHS 2023-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications …
File
… The Food and Drug Administration’s (FDA) Oversight and Regulation of Laboratory Developed Tests (LDTs) …