Compliance Regulations and Guidance Affecting your Industry

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.

Effective Date :This rule is effective August 3, 2009

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.

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.