FDA Finalizes Guidance on Completeness Assessments for Generic Drugs


FDA Finalizes Guidance on Generic Drug Completeness Assessments for Holders of Type II API DMFs Under GDUFAOn Tuesday, February 16th, the FDA announced the publication of “Completeness Assessments for Type II API DMFs Under GDUFA,” a final guidance that will help generic drug makers with the preparation of completeness assessments (CAs). The guidance was first released as a draft in 2012, and applies to “holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).”

Under GDUFA:

  • Type II API DMU holders, with products evaluated after October 1, 2012, are required to pay a one-time DMF fee when the DMF is first referenced in a generic drug submission submitted to FDA on the basis of a letter of authorization (LOA) from the DMF holder.
  • Type II API DMF holders evaluated prior to October 1, 20125 are required to pay the one-time DMF-fee when the DMF is first referenced in a new ANDA, an ANDA or PAS amendment, or an ANDA PAS on or after October 1, 2012.

The DMF fee for fiscal year 2016 is $42,170.

Once a Type II API DMF has been filed, the FDA will perform a CA to will determine the following:

  • Is the DMF active?
  • Has the fee been paid
  • Has the DMF been previously reviewed?
  • Does the DMF pertain to a single API?
  • Does the DMF contain certain administrative information?
  • Does the DMF contain all the information necessary to enable a scientific review?
  • Is the DMF written in English?

FDA states that the CA “does not replace the full scientific review, which determines whether the information contained in the DMF is adequate to support an ANDA regulatory action.” Furthermore, the guidance contains the entire CA form, which is provided as an appendix and includes an area for the Agency to make an expedited assessment request.

If the FDA finds the DMF to be complete, it “will be identified on FDA’s public Web site as available for reference in support of a generic drug submission.”

However, if it is found to be incomplete, “FDA will send the DMF holder a GDUFA DMF Incomplete Letter,” explaining why the DMF was deemed incomplete. In the guidance, FDA explains how to correct any deficiencies within a DMF, as follows:

“To remedy a GDUFA DMF Incomplete Letter and pass the CA, the DMF holder should submit an amendment to its DMF to correct the deficiencies identified in the Incomplete Letter, or, if FDA has determined that the DMF should undergo a complete update, the DMF holder should resubmit the DMF with that update. FDA will then assess the revised DMF’s completeness. If there are no deficiencies at this time, FDA will declare the DMF to be complete and to have passed the CA.”

Additionally, the Agency states that it will work with DMF holders to provide guidance on how to revise an incomplete DMF so it may be found complete upon re-submission.

Are you a holder of a Type II API DMF? Do you have a generic product on its way to approval? Is your product already approved by an ANDA? We can help with all regulatory aspects of your generic or branded pharmaceutical product. To learn more about how we can help you, contact us today.