New Drug Applications and Abbreviated New Drug Applications;Technical Amendment

• Date: November 04, 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 correct the address for the Orange Book Staff in 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 July 24, 2009

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