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Executive Briefing Series (formerly The Food & Drug Letter)
June 15, 2012 | Full Issue in PDF Format
The FDA will soon require drug and biologics makers to submit all new product applications in an electronic format. And within a few short years, the agency will stop accepting files submitted on a compact disc. Instead, all applications will have to flow directly and electronically from the applicant’s computer to the agency’s database. Additionally, sponsors will have to format their applications to comply with the FDA’s standards for electronic common technical documents, or eCTD. Should an application not comply, it will simply bounce back. The bottom line? Companies have only until 2017 to engineer systems and train personnel to deal with the new FDA requirements. Use this issue of The Food & Drug Letter to better understand the agency’s requirements for electronic submissions and how you can design an integrated system that proves both compliant and efficient. Note: Some of the information in this issue of F&DL is based on remarks by Antoinette Azevedo, an electronic submissions expert and principal with e-SubmissionsSolutions.com, during a recent FDAnews webinar.
Beginning in fiscal year 2017, drug and biologics makers must be ready to submit to the FDA in electronic form all documents related to new drug applications (NDA), biologics license applications (BLA) and investigational new drug (IND) applications.
If sponsors expect to be ready to begin electronically submitting all applications by 2017, they must first build a framework for handling and retrieving documents and data in electronic form, creating properly formatted files, and authoring and submitting an eCTD.
Despite having an extra year before they must start submitting IND applications electronically to the FDA, companies should convert their IND process before NDAs and BLAs, in order to gain experience with smaller and less time-critical submissions.
Companies want to develop the most effective electronic system possible to ensure efficient and reliable submission and acceptance of eCTDs.
Many companies that submit improper eCTDs either failed to learn the intricacies of what goes into a validated eCTD or didn’t adopt the necessary process changes.
When preparing documents for an eCTD submission, sponsors must ensure that all materials are properly formatted so that the review can start on time and proceed smoothly.
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