DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Meeting is an excellent opportunity to learn the latest eCTD information and best practices. One of the most valuable sessions of the meeting is always the “Ask the Regulators” session, in which representatives from FDA answer questions directly from the attendees. This year, DIA scheduled two such sessions in addition to the FDA presentations on PDUFA VI Informatics. Following is a summary of some of the most useful pieces of information we gleaned from DIA’s RSIDM Ask the Regulators sessions.

DIA’s RSIDM Ask The Regulators Session

• FDA will hold a public meeting titled, “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards,” on 21 March 2018. FDA is seeking input from stakeholders, and discussion topics for discussion will include eCTD, the ESG, IDMP, safety reporting, and data standards initiative. Advance registration is required. More info is available in this federal register notice.
• FDA encourages all Sponsors to electronically sign the fillable application forms (e.g., Forms FDA 1571 and 356h). However, FDA will continue to accept an unsigned, fillable form along with a signed, scanned form if a sponsor is not using electronic signatures.
• Note that the FDA Form 1571 has been updated to include a new field, 6B. You can access the updated form here.
  • This will help FDA ensure sponsors are compliant with the eCTD mandate. Sponsors should begin using this new version immediately.
• CBER has a PDUFA VI goal to implement the popular 3rd ESG acknowledgement by September 2018.
  • CDER began using the 3rd acknowledgment in 2016. It provides a “human readable” PDF confirming that your eCTD submission has been received by the review division.
• The ESG receives between 5,000-6,000 help desk tickets per month. The ESG staff is actively working to improve the ESG website and FAQ documentation so that more common issue scan be resolved by users without the need to contact the help desk.
• CDER’s Johnathan Resnick confirmed that for annual reports to an approved ANDA, BLA, or NDA, only a Form FDA 2252 is required. A Form FDA 356h is not required to be submitted with these submissions.
• CDER’s Norman Schmuff confirmed that a module 2.3 Quality Overall Summary is generally not necessary for an IND.