Gary Gensinger gave the US eSubmission update. The most interesting point that Gary made was in the "myth busting" department. Gary told us "There is no advantage to submitting in paper over electronic. In fact, it's the opposite - you are likely to get more questions." This stands to reason if you put yourself in the reviewer's shoes. For eCTD, the reviewer finds all of the documents organized in a well understood structure, can search for documents using a full text index, and can access documents instantly. For paper, the reviewer must determine which volume he or she needs, retrieve it from a document room, and deal with the delay if someone else has already checked it out.
Gary listed the advantages of eCTD as seen by FDA as:
- Supporting a better, more comprehensive review
- Providing for a more efficient and effective review process
- Promoting standardization
- Promoting operational efficiency
Gary was enthusiastic about the gateway, especially combined with the eCTD format. He mentioned that with an eNDA, a submission took two to three days to reach reviewers, but an eCTD submitted through the gateway reaches reviewers in as little as an hour. The agency persective dovetailed nicely with what I have been hearing from sponsors. For example, Monte Levinson of Zymogenetics, as part of the excellent presentation "IND in eCTD Format: eCTD on a Shoestring", mentioned that use of the gateway is a key part of his company's motivation for moving to eCTD, and that cutting days off the schedule for printing, binding, and delivery is seen as a huge benefit in his organization. Other sponsors were interested to learn that the gateway can be used even if submissions are outsourced provided the right authorizations are filed.
In another session, Joe Montgomery of the FDA addressed recent problems some applicants experienced with the gateway. It turns out that submissions of > 70 GB sometimes time out - FDA expects this problem to be fixed soon.
