The FDA has published guidance for the submission of facility information that is required to assure the shorter review timeframe for priority submissions.  This is a new provision of the GDUFA II negotiation and appears in the Commitment Letter. This pre-submission must be into OGD 2 months prior to submission of the priority application, supplement, or amendment.  It is designed to obtain a jump on assigning inspections for the facilities (manufacturing, testing, and bioequivalence) that will be contained in the applications.  This will be necessary to meeting the shorter priority review timelines by allowing FDA to determine if inspections of facilities are necessary and to plan for those inspections that are required.  Firms that fail to submit the pre-submission, or submit an incomplete pre-submission, or add facilities in the actual submissions will lose the opportunity for the shorter time frame review, although the application would still retain its priority status, but the standard goal date will apply.

The guidance provides information on FDA expectations for the pre-submission correspondence in terms of:

  • Content of the pre-submission
  • Statement of eligibility of priority review
  • Manufacturing process and testing facility information
  • Information about the drug product and drug substance
  • Information about the manufacturing process for drug substance and drug product
  • Manufacturing and testing for non-drug constituent parts and combination products
  • Information of bioequivalence sites
  • Study information

The ANDA should generally be submitted not longer than 3 months after the pre-submission correspondence.

There is also information on how and when to obtain pre-assigned ANDA numbers for the pre-submission. The format of the submission is also outlined, as well as where, and how to submit. It also contains a lot of information relative to how the OGD makes its final determination of the acceptability of the notice and how the sponsor will be notified.  To review the guidance document please click here. It is recommended that firms that wish to submit an ANDA that meets the priority review, study this document carefully and, if there are any questions, it is suggested that they be submitted to OGD well in advance of the timing for the pre-submission.