Electronic submissions 505 NDAs

Providing Regulatory Submissions in Electronic Format - NDAs ... 

This guidance document describes how a New Drug Application (NDA) may be sent electronically to the FDA. The guidance defines how the files in the electronic submission should be structured for FDA review. 

Essentially, the eCTD is a transport format for facilitating electronic submissions. The eCTD serves as an interface for industry-to-agency transfer of regulatory information while at the same time, taking into consideration the facilitation of the creation, review, life cycle management, and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The eCTD represents a major advance in the submission of information to support an NDA. In the future, companies may be able to send their submissions to several regulatory authorities simultaneously with a single stroke of a computer key. 

Examine electronic submission options. Most FDA submissions can be made manually (paper) or electronically. Obviously, the electronic submission process is more efficient, particularly when delivering large documents (INDs routinely run over 5,000 pages NDAs may be even larger), ffowever, there are some additional considerations. 

Electronic Submissions Training. Instructs reviewers on how to search for a specific NDA via the EDR Intranet site and to map the drive path of the folder. Acrobat Exchange is then used to open, navigate, view, follow links, create electronic notes, and copy and paste text, tables, and graphics into other applications from a sample electronic NDA. 

Currently, most INDs are submitted in paper form, often accompanied by an electronic disk with hyperlinks. Purely electronic submissions are still rare, in large part because of a lack of standardization and electronic sophistication on the part of the FDA. There is currently a Clinical Data Interchange Standards Consortium (CDISC) test underway assuming it proves successful, it is likely that CD ISC will emerge as a common electronic submission standard for INDs, New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs) over the next three to five years. 

NDA can be agreed, and technicalities surrounding electronic submissions can also be arranged. 

Discussion of the NDA format, including provision of an electronic submission... 

However, adoption of ELNs as a standard tool within corporate research was hampered by both the legal and regulatory requirements of the time. The FDA, the federal courts, and the USPTO were not really aligned to adoption of electronic records for NDA submission or for patent purposes. This was to... 

As preparations for the submission of an NDA begin, there needs to be a pre-NDA meeting with the EDA reviewing division. This meeting focuses on format, not content, and is important to eliminate delays that can occur when an NDA does not meet the specific needs of the assigned reviewers at the EDA (21 CER 312.47). The sponsor should provide to the FDA an idea of the t)q)es and volume of information to be submitted, as well as the plan for data summary, presentation and analysis. The FDA should provide to the sponsor any specific requests for the display and analysis of data. Electronic formats and requests have become more routine, and a good understanding of what is plaimed and needed can help improve efficiency and minimise later difficulties. 

In total, the NDA consisted of 732 paper volumes and 1200 electronic volumes, equating to approximately 2000 paper volumes. The total review time from submission to final approval was 1 day under 10 months. It was only through careful planning, and teamwork and the collaborative efforts of both the FDA and the company submission team that this became a success. The critical factors contributing to this success are summarized below. 

Electronic Regulatory Submissions and Review (CDER) This document (from http //www.fda.gov/cder/regulatory/ersr/default.htm) provides specific ESG guidance for CDER submissions, including NDAs, INDs, and DMFs. 

Sample Electronic NDA Submission Postmarketing Adverse Events Reporting... 

A further development related to the CTD is the move toward submitting it electronically, a submission format called e-CTD that was initiated through the ICH. In this format, information is contained in individual files that are associated with a backbone. In this way, information that is submitted as part of one application can be used in another application simply by providing information concerning where it is located in the sponsor s accumulating database. The FDA actively encourages NDA submission in the e-CTD format. ICH Guideline M4, The CTD, provides more information on this submission format. 

The best NDAs have a table of contents before the EOP2 meeting, and are built as the various component nonclinical and clinical study reports become available. Most companies do this both electronically and as paper hard copy. At present, FDA requires the submission of both, although PDUFA requires FDA to be able to accept just an electronic version by 2002. The structure is well described in the regulation, which the student is again urged to read. 

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