Related Links
Global Regulatory Agencies
United States
Food and Drug Administration (FDA) - Center for Biologics Evaluation and Research (CBER)
CBER is a center within the FDA that regulates biological and related products, including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER)
CDER is a center within the FDA that evaluates new drugs for safety and effectiveness before they are sold to American consumers.
Food and Drug Administration (FDA) -International Organizations and Foreign Government Agencies
The FDA has provided a list of all international organizations and global government agencies through the Office of International Programs at the FDA.
Canada
Health Canada
Health Canada is the governing body of Canada that regulates healthcare, new drug development and other health products.
European Union
European Medicines Agency (EMEA)
The EMEA is the regulatory body that is responsible for the scientific evaluation of applications for European marketing of medicinal products.
Germany
Paul-Ehrlich-Institut
The Paul-Ehrlich-Institut is a center within the Federal Republic of Germany that is responsible for evaluation and approval of biological medicinal products such as vaccines for humans and animals, as well as medicinal products containing allergens, antibodies, blood and blood products, etc.
India
Department of Biotechnology, Government of India
This department is set up under the Ministry of Science & Technology for the government of India. It is primarily responsible for the development of modern biology and biotechnology within the country.
Japan
Pharmaceuticals and Medical Devices Agency (PMDA)
The PMDA is the governing body of Japan that is responsible for the aid of adverse health effect, evaluation and approval of pharmaceutical drugs, as well as maintaining safe use and promotion of pharmaceutical drugs.
Japan Science and Technology Agency (JST)
The JST has a mission of promoting science and technology in Japan by encouraging consistent research and development to the commercialization of the product, and disseminating scientific and technological information.
P.R. China
State Food and Drug Administration
The State Food and Drug Administration of China is the regulatory authority on the safety management of food, pharmaceuticals and cosmetics.
Switzerland
Swissmedic, Swiss Agency for Therapeutic Products
Swissmedic is the Swiss regulatory body responsible for the safety and licensing of medicines and medical devices both before and after they are on the market.
Related Organizations / Programs
Biotherapy Development Association (BDA)
The BDA is an international organization based in Munich, Germany that is devoted to the education, pre-clinical and clinical research and development of biological therapies for cancer.
Canadian Institutes of Health Research (CIHR)
CIHR is the government of Canada's health research funding agency that supports the work of researchers and trainees in universities, teaching hospitals and research institutes.
Cancer Research Institute
The Cancer Research Institute is an organization that is dedicated to conquering cancer through immunology. It provides funding to academic researchers at top institutions around the world.
Clinical Immunology Society
The Clinical Immunology Society facilitates education, translational research and novel approaches to therapy in clinical immunology to promote excellence in the care of patients with immunologic/inflammatory disorders.
Federation of Clinical Immunology Societies (FOCIS)
FOCIS is a federation of non-profit organizations committed to understanding and treating immune diseases.
National Cancer Institute
The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
National Cancer Institute- Cancer Therapy Evaluation Program (CTEP)
CTEP funds a national cancer research program and clinical trials with a focus on translational research.
National Cancer Institute (NCI) Research & Funding
The NCI has provided a segment of their web site that is dedicated to research and funding opportunities for cancer researchers.
National Cancer Institute of Canada
The National Cancer Institute of Canada is the premier organization that is dedicated to supporting cancer research across the country.
National Center for Biotechnology Information (NCBI)
NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information.
National Institutes of Health (NIH)
The NIH is the primary Federal agency for conducting and supporting medical research and is a part of the U.S. Department of Health and Human Services.
National Library of Medicine
The National Library of Medicine is the world's largest medical library and provides information and research services in all areas of biomedicine and health care.
Research Resources
Community of Science (COS)
COS is a global resource for hard-to-find information critical to scientific research and other projects across all disciplines (i.e. funding, networking, promotion of research).
Computer Retrieval of Information on Scientific Projects (CRISP)
CRISP is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions. The database, maintained by the Office of Extramural Research at the National Institutes of Health, includes projects funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDCP), Agency for Health Care Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH).
Database for Annotation, Visualization and Integrated Discovery (DAVID)
DAVID provides a comprehensive set of functional annotation tools for investigators to understand biological meaning behind large lists of genes (list of capabilities on web site).
Genesis - Bioinformatics Graz
Genesis is a platform that simultaneously visualizes and analyzes a whole set of gene expression experiments.
Genomica - Segal Lab of Computational Biology
Genomica is an analysis and visualization tool for genomic data, which can integrate gene expression data, DNA sequence data, and gene and experiment annotation information.
International Immunogenetics Information System
The International Immunogenetics Information System is a genome and structure database that specializes in immunoglobulins (IG), T cell receptors (TR), major histocompatibility complex (MHC), immunoglobulin superfamily (IgSF), major histocompatibility complex superfamily (MhcSF) and related proteins of the immune system (RPI) of human and other vertebrate species.
Journal of Immunotherapy
The Journal of Immunotherapy is the official journal of iSBTc.
NIH - NHLBI - PACT Program
The Production Assistance for Cellular Therapies program (PACT) of the National Heart, Lung, and Blood Institute (NHLBI) is designed to develop novel somatic cellular therapies that will aid investigators by providing production assistance in areas ranging from translational development to the scale-up of a product that is intended for use in human clinical trials. The Education Training Program promotes the field of cellular therapy and reaches out to investigators new to the field to provide recommended applications of the current Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) guidelines.
UCSC Genome Bioinformatics
The Genome Bioinformatics program contains the reference sequence and working draft assemblies for a large collection of genomes.
