Category Archives: The Food & Drug Letter

Abstract

By | The Food & Drug Letter | No Comments

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.