USA – FDA moving away from PDFs to digital submissions

After a successful pilot program, the US Food and Drug Administration (FDA) is fine-tuning a transition to all-digital submission of safety data from clinical trials of investigational drugs.

The goal is to modernize the submission of regulatory data by shifting from use of multiple PDF documents into a digital submission format with structured data elements “that will allow us both to improve the data quality and also allow us to use new analytic tools,” to make other novel uses of submission data, said Meredith Chuk, MD, Acting Associate Director for Safety with FDA’s Office of Oncologic Diseases.

Speaking of the submission of certain required reports of serious safety events occurring in clinical trials of investigational drugs, Chuk said, “The current method for submission of these reports is actually as PDF forms, and it’s extremely inefficient,” since FDA may receive as many as 50,000 safety report forms per year. Chuk spoke Tuesday at a day-long meeting focused on modernizing FDA’s data strategy. “Review and tracking of these important safety data by medical reviewers is challenging.”…