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… The Food and Drug Administration’s (FDA) Oversight and Regulation of Laboratory Developed Tests (LDTs) …
The Genomics Landscape
In the November 2023 edition of The Genomics Landscape, NHGRI Director Eric Green, celebrates the 30th anniversary of the NHGRI Intramural Research Program as well as announces the launch of a new digital history archive.
… at the University of Chicago highlight tissue-specific regulation of genes that lead to differences between … understanding of evolution as well as the role of genomic regulation in human traits. This research was funded by the …
FAQ
On October 10, 2024, NHGRI hosted a pre-application webinar for the Population Genomic Screening in Primary Care NOFOs: RFA-HG-24-021, RFA-HG-24-022, and RFA-HG-24-023. These FAQs contain questions answered during that webinar.
… - Eligibility Information” can apply to the NOFOs. Will FDA review/approval of return of results to participants be … In other words, will the project need an IDE w/ the FDA? Most likely no, but if a study proposes to use a … the investigator of the study must consider FDA's IDE regulation before proceeding with enrollment. In the context …
The Genomics Landscape
In the November 2019 edition of The Genomics Landscape, NHGRI Director Eric Green highlights the International Common Disease Alliance's scientific plenary and launch meeting in September, which included an international panel on opportunities emerging outside the U.S., North America, and Europe; discussions about polygenic risk scores; and an overview about data platforms, data sharing, and ethics.
… diversity in health-related research” NIH & NHGRI News FDA approves new breakthrough therapy for cystic fibrosis …
News Release
NIH awards more than $64 million to for a database of human cellular responses called the Library of Integrated Network-based Cellular Signatures or LINCS.
… will leverage the U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System database to identify … from human skin cells. Such signatures may help repurpose FDA-approved drugs to lessen adverse events and help in …
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 …
Research at NHGRI
The Democratizing Education for Sickle Cell Disease Gene Therapy project developed patient-focused educational materials for the sickle cell community.
… In December 2023, the U.S. Food and Drug Administration (FDA) approved two gene therapies to treat sickle cell …
The Genomics Landscape
In the March 2018 edition of The Genomics Landscape, NHGRI Director Eric Green highlights a strategic planning effort to establish a 2020 vision for genomics.
… Opportunities Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research (SBIR) - Parent … Applications Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer (STTR) - Parent …
Fact Sheet
Sickle cell disease resources for healthcare providers
… suspension DailyMed, National Library of Medicine FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease Casgevy FDA Lovotibeglogene autotemcel Lovotibeglogene autotemcel … suspension DaliyMed, National Library of Medicine FDA Approves First Gene Therapies to Treat Patients with …
Staff
Dr. Michael Erdos is an Associate Investigator in the Molecular Genetics Section of the Center for Precision Health Research.
… treatment strategies are in the application process for FDA approval. In the context of complex genetic disease, Dr. … stiffness, and ultimately a modest extension in lifespan. FDA approved lonafarnib (a farnesyltransferase inhibitor) for … Chromatin stretch enhancer states drive cell-specific gene regulation and harbor human disease risk variants . Proc. …