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National Advisory Council for Human Genome Research
The Director's Report-Related Documents contain links to materials supplemental to Dr. Eric Green's Director's Report presentation to the National Advisory Council for Human Genome Research in May 2024.
… Health 6 Executive Order on Women’s Health Research 7 FDA Finalizes Rule for LDT Oversight and Regulation FDA Finalized Rule Final Regulatory Impact Analysis of the …
File
… 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 …
The Genomics Landscape
In the June 2024 issue of The Genomics Landscape, NHGRI Director Eric Green recognizes the 2023 recipients of the Bettie J. Graham Leadership Award for Enhancing DEIA in the Genomics Workforce.
… is the process by which the proteome is regulated. This regulation can be carried out by other proteins and often …
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 …
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 …
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 …
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 …
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 patients
… What is Gene Therapy? U.S. Food and Drug Administration (FDA) Gene Therapies for Sickle Cell Disease Cure Sickle … suspension DailyMed, National Library of Medicine FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease Casgevy FDA Lovotibeglogene autotemcel Lovotibeglogene autotemcel …