Electronic submissions options

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. 

Draft Guidance Providing Regulatory Submissions in Electronic Format-Prescription Drug Advertising and Promotional Labeling. Optional format PDF. (Issued January 2001, Posted January 30,2001)... 

In terms of electronic publishing, the NLM launched PubMed Central this year in an effort to reduce the time from article submission to publication and to increase the dissemination of new information in the life sciences. PubMed Central eventually will contain two types of data depositories The first will be peer-reviewed content from journals that will partner with NLM to make their content available free to the public and the second depository will contain articles submitted directly by authors. Ideally, PubMed Central would increase the options for researchers and academicians to publish their research. This is a very new concept in medical publishing and it will be exciting to watch how it takes shape in terms of the quality of research articles submitted and the way in which the healthcare community embraces this new source of information. 

If this option is used, the AOBRD must meet the performance requirements of 395.15(i). In addition, the carrier and drivers must comply with the procedures of 395.15(b)-(h) which detail information requirements, reconstruction of records following failure, on-board information, submission of records, and maintenance of back-up electronic files. 

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