The FDA is strongly encouraging Industry to move from paper to electronic submissions in order to increase review efficiency, minimize delays in routing and tracking, and reduce archiving costs.

The table below shows that the number of electronic submissions has been dramatically increasing over the least several years. This indicates that companies are seeing the improved efficiency of the electronic process, which ultimately results in faster time-to-market.

*Numbers above for CBER and CDER combined

The bullets below summarize the advantages of electronic submissions.

• Increased efficiency of FDA review; searchable documents, compare multiple versions of documents (e.g. clinical protocols, product labeling), cut and paste functionality for formulating review.
• Reviewers have instant access to entirety of IND/BLA/NDA submissions throughout their lifecycle, internal routing of paper submissions to a reviewer can take several days
  
• Advantages in the above 2 bullets also apply on the industry side, allowing a company to respond faster to questions from the FDA
  
• Can use FDA Gateway to deliver submissions to reviewer in a matter of minutes versus 3-7 days for paper
  
• An eIND can be readily leveraged for an eventual a license application
  
• Significantly reduces storage space for archiving submissions
  
• Significantly reduces cost of shipping submissions
  

Although the FDA currently accepts both paper and electronic submissions, electronic review will eventually become the standard process. Making the transition now will put companies ahead of the game, leaving them well prepared when electronic submissions become mandatory.

Mr. Dan Offringa, ex-CBER Electronic Document Room IT Specialist, heads the BCG electronic submissions group. We welcome client inquiries as to how we can meet your e-publishing needs.

Contact President Jim Kenimer, Ph.D. or Mr. Dan Offringa to inquire about BCG's e-submission services.

Page Updated: February 13, 2008