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Pharmaceutical companies seek clarity on evidence needed for drug label change
(December 22, 2008)
FDA's Oncologic Drug Advisory Committee met with representatives from pharmaceutical companies Amgen and Imclone to discuss what types of studies need to be done before existing drug labels can be amended with new biomarker information.  

Statement regarding Genentech citizen petition filed with FDA
(December 16, 2008)
The pharmaceutical firm Genentech has filed a citizen petition with the Food and Drug Administration asking that the agency regulate all in vitro diagnostic tests intended for use in drug or biologic therapeutic decision making. 

Publication announcement - Public expectations for return of results from large-cohort genetic research
(December 11, 2008)
Participants in a series of focus groups felt strongly that anyone taking part in a large-cohort genetic study should have access to their research results, according to a new paper in the American Journal of Bioethics. 

Publication announcement - The health benefits of genomics
(November 19, 2008)
Obsolete models of research support and regulatory guidance severely threaten the promise of genetic medicine, writes Center Director Kathy Hudson in the November issue of Health Affairs. 

Center to hold GenePOPS on biobanks
(November 19, 2008)
The seminar, "Genetic Biobanks: Deposits, Withdrawals, and Consumer Protection," will take place at the National Press Club in Washington, DC on December 9. 

Survey Finds Wide Public Support for Nationwide Study Of Genes, Environment and Lifestyle
(November 12, 2008)
Four in five Americans support the idea of a nationwide study to investigate the interactions of genes, environment and lifestyle, and three in five say they would be willing to take part in such a study, according to a survey released today.  

Center Receives NIH Award to Study Direct-to-Consumer Genetic Testing
(October 28, 2008)
The National Human Genome Research Institute has awarded the Center a two-year grant to study the growing field of direct-to-consumer genetic testing. 

Publication announcement - Carrier screening for CF in US genetic testing laboratories: A survey of laboratory directors
(October 28, 2008)
Market pressures may have more influence on clinical practice than laboratory guidelines: That's one conclusion of a Center survey, which found that guidelines for cystic fibrosis carrier screening have only been partially adopted.  

Center convenes panel to guide future path
(October 28, 2008)
The Center convened leaders in science, policy, business, health, and academia to help better understand the rapidly evolving scientific landscape of human genetics and health care - and how the Center fits into it all.  

Novel forensic technique highlights need for greater privacy protection for research participants
(September 22, 2008)
Publication of a novel forensic DNA analysis technique this month drove the National Institutes of Health to remove aggregate genomic data from the public domain to protect research participants' privacy. 

Publication announcement - Preimplantation genetic screening: a survey of in vitro fertilization clinics
(September 22, 2008)
Most clinicians who offer preimplantation genetic screening believe that more research is needed to determine when -- or even whether -- the technique should be offered to patients, according to a Center survey.  

FDA questions laboratory-developed ovarian cancer test
(September 22, 2008)
FDA tells LabCorp that its OvaSure test lacks adequate clinical validation and therefore may harm the public.  

Reauthorization of DNA backlog grant program could expand forensic DNA collection
(August 13, 2008)
Two amendments to the Debbie Smith DNA Backlog grant program have sparked controversy and led some to argue that the original intent of the bill will be undermined. 

State actions point to need for federal leadership
(August 13, 2008)
Disparate state laws and state enforcement actions on direct-to-consumer genetic tests are clearly consequences of a void at the federal level, writes Center Director Kathy Hudson. 

Center launches new GINA resource
(July 23, 2008)
The Center has now launched "Project GINA" to disseminate information on the Genetic Information Nondiscrimination Act. 

Publication announcement: Policies must keep pace with genetic progress
(June 19, 2008)
Enactment of the Genetic Information Nondiscrimination Act of 2008 is a boon for individual patients and for genetic research, write Kathy Hudson and co-authors in the New England Journal of Medicine. But the bill is not a panacea, they note. 

Statement of Director Kathy Hudson regarding announced resignation of NHGRI's Francis Collins
(May 28, 2008)
It is no coincidence that Francis Collins's tenure at the National Human Genome Research Institute marked one of the most extraordinary periods in modern science. 

President Bush signs long-awaited Genetic Information Nondiscrimination Act
(May 21, 2008)
Signed into law today, GINA provides vital protection for Americans against the misuse of genetic test results by heath insurers and employers. 

Publication announcement: Engagement as a dialogue, not a lecture
(May 21, 2008)
In a recent issue of the online magazine Science Progress, Center authors Rick Borchelt and Kathy Hudson outline various modern approaches to engaging the public with science. 

Center to hold personal genomics seminar June 10
(May 15, 2008)
The seminar, "The Molecular Full Monty: Personal Genomes, Personal Health," will take place at the National Press Club at 2:00 pm. 

Genetic Information Nondiscrimination Act passes Senate
(April 24, 2008)
The Senate passed the Genetic Information Nondiscrimination Act unanimously. 

Marketing of unproven tests a threat to public health
(April 03, 2008)
Regulatory action by the FDA and FTC is key to the future of personalized medicine, according to a new paper in the journal Science. 

Center holds town hall meeting in Kansas City
(March 20, 2008)
The Center held its first town hall on genes, environment, and health in Kansas City, MO on March 8. 

GINA passes House for second time this Congress
(March 20, 2008)
On March 5 the text of the Genetic Information Nondiscrimination Act was added to the Paul Wellstone Mental Health and Addiction Equity Act (H.R.1424). The new bill passed the House 268-148. 

Study finds genomic profiling companies' claims lack scientific backing
(March 20, 2008)
An analysis published this month compares nutrigenomic companies' claims with available meta-analyses and finds that most are insufficiently supported by scientific evidence. 

Center to hold town halls on genes, environment, and your health in five U.S. cities
(February 21, 2008)
Town halls will take place on March 8 in Kansas City, MO; April 5 in Phoenix, AZ; April 19 in Jackson, MS; April 24 in Portland, OR; and May 13 in Philadelphia, PA. 

Center probes public opinion on inclusion of children in large-cohort genetic study
(February 06, 2008)
Focus group participants generally agreed that parents should have access to their children's genetic and medical test results during future large-cohort studies on the roles of genes and environment in disease. 

International Law Comparison Tool Now Available
(January 25, 2008)
The Center has added a new resource to its site, a database of laws in 16 countries related to human cloning, human genetic modification, and reproductive genetic modification. 

New Publication - "In Search of a Coherent Framework: Options for FDA Oversight of Genetic Tests"
(January 03, 2008)
The paper offers a comprehensive review of the Food and Drug Administration's efforts in genetic test regulation and presents options for a more active role for the agency going forward.