New Drug Applications and Abbreviated New Drug Applications; Technical Amendment

• Date: November 09, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to update agency contacts for patent information and patent notifications and to correct an inaccurate cross-reference. This action is being taken to ensure accuracy and clarity in the agency’s regulations.

Effective Date:This rule is effective March 6, 2009

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