FDA amend the draft guidance for priority pre-ANDA submissions.

Back in June 2017, the FDA released a draft guidance document which contained detailed information on the requirements and format of pre-submission facility correspondence (PFCs). This document has now been updated to update the submission criteria.

Until now, PFCs were submitted in non-eCTD format via the agency’s electronic submission gateway. The updated guidance document now states that these submissions must now be done in eCTD format. It also now states which sections of the eCTD structure the FDA deems relevant to the PFC application.

For companies that have already begun preparation work for their PFC in non-eCTD format, the FDA will accept the submission so long it is submitted before 6 December 2017. After this date, all submissions are to be made in eCTD. The FDA will also allow comments made in the original version so that they do not have to resubmit their comments.

To read the revised guidance document, click here.