OGD Delivers on First of Two Documents – Early!

Friday, September 1, 2017, the FDA issued MaPP 5200.14, a 43-page document that describes the Office of Generic Drugs’ internal policy and procedures for evaluating an ANDA for initial receipt as substantially complete for “receipt” (filing) purposes. We previously posted about this document here.

The MaPP also outlines the Refuse-to-Receive (RTR) limit on the types of deficiencies that will result in an RTR action, as follows:

Identify and list all deficiencies noted in review of Modules 1 – 5

  • RTR an ANDA that contains one or more major deficiencies pursuant to the guidance for industry ANDA Submissions – Refuse-to-Receive Standards, as revised.
  • RTR an ANDA that contains ten or more minor deficiencies pursuant to the guidance for industry ANDA Submissions – Refuse-to-Receive Standards, as revised.
  • Send an IR to the applicant if the ANDA contains nine or fewer minor deficiencies, providing the applicant the ability to remedy these deficiencies.
  • RTR the ANDA if the applicant does not remedy all deficiencies within 7 calendar days of FDA sending the IR.

The remainder of the MaPP provides a detailed, up-to-date ANDA checklist that is used by OGD’s Division of Filing Review in determining whether the ANDA submission is deemed substantially complete for receipt.  The document also notes that many applicants include a completed copy of the checklist in their ANDA submission, but, according to OGD, that is not necessary or recommended.  The checklist follows the Common Technical Document (CTD) format.   The checklist is very detailed and includes new terms and requirements regarding the Reference Listed Drug and reference standards, the 2014 stability requirements (including number of batches), and requirement to use 2 API sources per strength, just to name a few. The bioequivalence section is also greatly expanded. A full copy pf the MaPP can be found here.

Hopefully this document will lower the RTR rate and help firms submit more complete applications.