From moving trucks to hitting “send”, biopharmaceutical companies need a stable and reliable system to submit New Drug Applications

FDASIA grants FDA authority to require electronic submission of new drug and biologic applications

11.01.13 | By Kristin Van Goor

Less than 15 years ago, submitting an application to the Food and Drug Administration (FDA) for the approval of a new medicine generally involved loading docks, moving trucks, and enough paper to obliterate a small tree farm.  Today, those data once supplied on hundreds of thousands of paper pages are now a structured collection of electronic files submitted to the FDA through a secure portal. 

FDA’s transition to the requirement for industry to provide new drug applications (NDAs) electronically evolved over time – from reviewers receiving submissions on 9-track tapes in the 1980s to the first computer-assisted NDAs (CANDAs) in the 1990s to the development of guidance by the International Council on Harmonisation (ICH) in the early 2000s on the structure and specifications for electronic submission of applications. 

The biopharmaceutical industry has long supported the transition to electronic submission of information to the FDA as evidenced by the inclusion of electronic submission goals in the past three reauthorizations of the Prescription Drug User Fee Act (PDUFA).  Realizing the importance of further standardizing electronic submissions of NDAs, the PDUFA V Goals Letter, paired with new authorities granted to the FDA under Section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA), requires that applications submitted to the FDA be in accordance with standards and formats specified in final guidance from the FDA.  With the issuance of draft guidance on electronic submissions earlier this year, the FDA has taken a significant step towards implementing this requirement as early as the end of 2015. 

As all stakeholders work together to prepare for these pending requirements and as an increasing number of stakeholders start sending electronic submissions to the FDA, the reliability and capacity of the portal, known as the Electronic Submissions Gateway (ESG), by which FDA receives submissions is of paramount importance.  Although moving trucks bringing new drug applications to FDA may be a thing of the past, the FDA still receives the same, if not a greater, volume of data, all of which goes through the ESG.  Therefore, all stakeholders in the drug development and regulatory review process – from biopharmaceutical companies seeking to submit new drug applications to the FDA to FDA seeking to receive new information regarding the safety of marketed drugs to patients eager for the review process to begin to speed the availability of new medicines - have a shared interest in the stability and security of the ESG.  

When the ESG slows down or becomes temporarily unavailable, the effect on a biopharmaceutical company is akin to a business losing email service.  The chaos that ensues when a business’ email server goes down is probably familiar to most people: employees launch into individual trouble-shooting efforts by sending test emails within and outside the organization to determine the scope of the issue, IT staff go into “all hands on deck” mode, meetings are missed or delayed due to essential information that was only saved in an email, and resources are expended to rapidly fix the issue and return the business to productively.

As with any critical piece of IT infrastructure, it is important to maintain high expectations for the functioning of the ESG and to ensure that the FDA has both the technical expertise and resources needed to support this critical system. 


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