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.

Read More


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,…

Read More