A new electronic submission process the FDA is planning would allow trials to submit safety data digitally, eliminating the need to manage multiple PDF-format documents and enabling the agency to analyze data more efficiently.

The agency is working on drafting guidances on the new process, which will allow trials to submit safety data directly from their databases through an FDA portal to the agency’s Adverse Events Safety Reporting System.

The switch to digital submission will start two years following the finalization of the guidance documents.