The Food & Drug Letter

Creating an Internal Framework for Application eSubmission

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.

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Abstract

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,…

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