U.S. Food and Drug Administration Center for Drug Evaluation and Research

CDER - Center for Drug Evaluation and Research Logo

Small Business Assistance

CDER Home Site Information Comments and Feedback What's New CDER Navigation Bar

CDER ArchivesSpecific AudiencesCDER CalendarRegulatory InformationDrug InformationAbout CDERSide Navigational Buttons

botside1.gif (9072 bytes)

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.

ToTop  Back to Top          Back Back to Small Business 


FDA/Center for Drug Evaluation and Research
Last Updated: December 2, 2005
Originator: OTCOM/DML
HTML by  SJW