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The mission of FDA's Center for Drug Evaluation and
Research is to assure that safe and effective drugs are available to the American people.
This section has definitions and interactive charts which provide basic information
for small business owners and others who are unfamiliar with the new drug development and
approval process.
Orphan Drugs
The term "orphan drug" refers to a product that treats a rare disease affecting
fewer than 200,000 Americans. This page includes links to The Orphan Drug Act and related laws and
regulations, orphan product
designation, and frequently asked
questions.
International Conference on
Harmonization The ICH is a cooperative effort between the drug regulatory
authorities and the pharmaceutical company professional organizations in the European
Union, Japan, and the United States to reduce the need to duplicate the testing conducted
during the research and development of new drugs. This page provides a link to the ICH
home page and ICH guidances. Please see the International
Activities web page for CDER's work with ICH.
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FDA/Center for Drug Evaluation and Research
Last Updated: December 2, 2005
Originator: OTCOM/DML
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