Global Agencies
U.S. Agencies
Other Organizations
Regulatory References

U.S. Government and Regulatory Agencies:

Genomics at the FDA
Pharmacogenomics allows us to identify sources of an individual’s profile of drug response and predict the best possible treatment option for this individual. The use of genomic information, accelerated by the sequencing of the human genome and the advent of new tools and technologies, has opened new possibilities in drug discovery and development. Consequently, regulatory science and regulations need to be set in place appropriately.
Web Site:http://www.fda.gov/cder/genomics/default.htm

Center for the Advancement of Health
The Center for the Advancement of Health proposes to launch an expanded and sustained effort to provide leadership and coordination that will help ensure that the nation will capture the full value of its investment in health research.
Web Site:http://www.cfah.org/

FDA Regulations Relating to Good Clinical Practice and Clinical Trials
FDA has Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA.
Web Site:http://www.fda.gov/oc/gcp/regulations.html

U.S. Food and Drug Administration (FDA) 
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
Web Site:http://www.fda.gov/

National Institutes of Health
The National Institutes of Health (NIH) is the steward of medical and behavioral research for the Nation. It is an Agency under the U.S. Department of Health and Human Services.  The NIH comprises the Office of the Director and 27 Institutes and Centers. The Office of the Director is responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all NIH components.
Web Site: http://www.health.nih.gov/

NIH Road Map
The NIH Road Map is purposed to identify major opportunities and gaps in biomedical research that no single institute at NIH could tackle alone but that the agency as a whole must address to make the biggest impact on the progress of medical research. The opportunities for discoveries have never been greater, but the complexity of biology remains a daunting challenge. NIH is uniquely positioned to catalyze changes that must be made to transform our new scientific knowledge into tangible benefits for people.
Web Site: http://nihroadmap.nih.gov/


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