Chemistry/Micro/Labeling Review Acceptable?

If there are deficiencies involved in the Chemistry/Manufacturing/Controls, Microbiology or Labeling portions of the application, these deficiencies are communicated to the applicant in a facsimile. The facsimile instructs the applicant to provide information and data to address the deficiencies and provides regulatory direction on how to amend the application. Once the above sections are found to be acceptable, as well as, the preapproval inspection and bioequivalence portion of the application, then the application moves toward approval. If after undergoing a final Office-level administrative approval review by all review disciplines without any further deficiencies being noted, the application can be approved (See ANDA Approval).