Investigational New Drug Applications; Technical Amendment

• Date: November 04, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency’s regulations.

Effective Date: This rule is effective October 29, 2009

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