Drugs
Small Business Assistance: 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.
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Drug Approval Application Process This web page provides an example on how a drug sponsor can work with FDA's regulations and guidance information to bring a new drug to market, from clinical trials to postmarketing surveillance.
- Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting (12/2/2005)
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Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
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Combination Products Program Combination products often involve cutting edge, novel technologies that raise not only unique scientific and technical questions, but also regulatory challenges related to where and how they should be regulated in order to ensure adequate and consistent regulatory oversight. (Posted 9/5/2002)
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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.
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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 Programs web page for FDA's work with ICH.