Center for Devices and Radiological Health (CDRH)
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (m
Center for Disease Control (CDC)
The Centers for Disease Control and Prevention (CDC), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting public health activities in the United States. CDC’s focus is not only on scien
Center for Drug Evaluation and Research (CDER)
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.
European Medicines Agency (EMEA)
The European Medicines Agency (EMEA) is a decentralized body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for hu
European Pharmacopea (EP)
The European Pharmacopoeia, also known as the EDQM (European Directorate for the Quality of Medicines & HealthCare, Council of Europe), is an European Organization involved in harmonization & coordination of standardization, regulation & quali
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 a
Government Printing Office (GPO)
The U.S. Government Printing Office (GPO) provides publishing & dissemination services for the official & authentic government publications to Congress, Federal agencies, Federal depository libraries, & the American public.
International Council on Harmonization (ICH)
ICH is a joint initiative involving both regulators and research-based industry representatives of the European Union, Japan and the USA in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality an
Japanese Pharmacopea (JP)
English version of the The Japanese Pharmacopoeia, Fifteenth Edition (2001).
National Institutes of Health (NIH)
NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the bu
U.S. Pharmacopea-National Formulary (USP-NF)
USP-NF Online guides users through the pharmaceutical process. It is a source of FDA-enforceable quality standards for drugs, dietary supplements, excipients, procedures for tests, assays, analytical methods, and more.