Helpful Links

Food and Drug Administration (FDA)

FDA, an agency within the U.S. Department of Health and Human Services, is responsible for ensuring human and veterinary drugs, biological products, and medical devices are safe and effective. FDA guidance documentation may be issued under the relevant centers, i.e., Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health, and/or the Office of Combination Products. For an exhaustive listing of FDA information, please refer to http://www.fda.gov.

European Commission (EC)

The EC is responsible for developing and adopting community legislation and guidance regarding pharmaceutical medicinal products for the European Union (EU), including granting marketing authorizations for medicinal products in the EU. For an exhaustive listing of EC information for the pharmaceutical sector, please refer to http://ec.europa.eu/enterprise/pharmaceuticals/.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

The ICH is a joint regulatory/industry project to harmonize the process for developing and registering new medicinal products in Europe, Japan and the United States, in order to ensure a timelier introduction. The ICH produces guidelines for adoption in the three ICH regions. For an exhaustive listing of ICH information, please refer to http://www.ich.org.

Additional Statutory and Regulatory Information

For information pertaining to Congressional Acts, please refer to http://thomas.loc.gov/. For information pertaining to United States Code provisions please refer to http://www.law.cornell.edu/uscode/. Finally, for additional regulatory information, please refer to http://www.gpoaccess.gov/.