Effective July 15, 2009, the U.S. Food and Drug Administration (FDA) will require applicants of an abbreviated new drug application (ANDA) to submit all data from bioequivalence studies that have been conducted on the particular drug formulation submitted for approval. Currently ANDA applicants (typically generic drug manufacturers) are only required to submit studies which demonstrate bioequivalence, however, this new rule will require the submission of all studies conducted on the same product, including any studies which do not demonstrate bioequivalence. It is believed that enabling the FDA to examine all available information should assist in the accurate determination of whether the generic drug in fact bioequivalent to the reference listed drug. Additionally, applicants will also be required to submit an annual report of post marketing bioequivalence studies and data conducting on the approved drug formulation. The FDA intends to issue a short guidance document for ANDA applicants providing additional information on this amendment and a recommended format for the submissions.
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