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New Drug Development and Review Process

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