Links

Government Organizations:

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/

Associations and Other Resources:

Biotechnology Industry Organization
Biotechnology Industry Organization (BIO) represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.
Web site: http://www.bio.org/

BIOCOM
BIOCOM represents the life sciences industry in the Greater San Diego region as a life science industry association representing more than 450 member companies in San Diego and Southern California. The association focuses on initiatives that positively influence the growth of the life science industry, including capital formation, public policy, workforce development, and scientific discovery and development.
Web site: http://www.biocom.org/

California Healthcare Institute
California Healthcare Institute (CHI) takes on a mission is to research, develop, and advocate policies and actions that promote biomedical science, biotechnology, pharmaceutical and medical device innovation in California. Tax incentives, including federal and state R&D credits, and the state Manufacturers Investment Tax Credit play a key role in advancing breakthrough medical research. However, biotech companies that have long R&D cycles and operate at a loss for many years remain unable to take advantage of these tax credits. CHI remains committed to making the federal R&D credit permanent. On the state level, CHI will fight to maintain existing tax benefits (i.e., state R&D credit and the MIC) and look for opportunities to create incentives for emerging biotech and medical device companies.
Web site: http://chi.org/

CenterWatch Drugs in Clinical Trials Database
The Drugs in Clinical Trials Database is a comprehensive online resource offering detailed profiles of new investigational treatments in phase I through III clinical trials. Updated weekly, the online directory provides information on more than 2,000 drugs for more than 800 disease conditions worldwide in a well-organized and easy-to-reference format. Detailed profile information is provided for each drug.
Web site: http://www.centerwatch.com

Drug Information Association
The Drug Information Association (DIA) is a non-profit, multi-disciplinary, member-driven scientific association with a membership of over 22,000. These members are primarily from the regulatory agencies, academia, contract support organizations, pharmaceutical, biological and device industry, and from other health care organizations. The association provides a neutral, global forum for the exchange and dissemination of information on the discovery, development, evaluation and utilization of medicines and related healthcare technologies.
Web site: http://www.diahome.org

Tufts Center for Drug Development
The Tufts CSDD's mission is to provide strategic information for drug developers, regulators, and policy markers on improving the quality and efficiency of pharmaceutical development, research, and utilization.
Web site: http://csdd.tufts.edu/