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Feb 25, 2014

What Does the New FDA Guidance on Electronic Submissions Mean?




By Cindy Fazzi, Marketing Communications, MasterControl Inc.

Two years after the Food and Drug Administration Safety and Innovation Act (FDASIA) became law, the FDA has taken a step forward in requiring electronic submissions under FDASIA. Do you know how this new requirement is going to affect your submissions?
The FDA released a draft guidance  in early February to address which submissions must be submitted electronically, which submissions are exempted, which ones can be waivered, and when this new requirement will take effect.
Under the new guidance, the agency will require the following to be submitted electronically: certain INDs, NDAs, ANDAs, and certain BLAs. The requirement will take effect “no earlier than 24 months” after the FDA issues a final guidance. The other areas (exemptions, waiver) are not as clear and the agency still has to work on the details.

An article by Alexander Gaffney published by the Regulatory Affairs Professionals Society (RAPS) called the guidance “a roadmap” for pharmaceutical and biopharmaceutical companies on electronic submission. The article said that the new guidance is somewhat of an “anomaly” because it doesn’t just provide formal agency recommendations, it also contains some binding provisions.
With the release of the new guidance, it’s a good time for organizations still using paper-based or hybrid QMS to consider switching to an automated system. Now is the time to educate your organization about why the FDA is moving toward mandatory electronic submission under FDASIA—to improve the quality of industry applications and increase the efficiency of FDA reviews.
Cindy Fazzi, a marketing communications specialist at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.
Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or MasterControl Inc.

 







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