Applications for Food and Drug Administration Approval To Market a New Drug: Postmarketing Reports,

• Date: July 27, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug  application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking  this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA).  FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and  that the agency update the list quarterly.

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