The Food and Drug Administration (FDA) today announced plans to hold a public hearing to solicit comments and information on the electronic submission of product information. The Agency is also interested in hearing the public’s perspectives on issues related to creating an electronic information exchange platform. Information provided at the hearing will help FDA shape a modern paperless submission process and help facilitate the effective use of submitted information, including drug safety information.
“The FDA sits on the world’s singular repository of drug safety and effectiveness information, but so long as a lot of it remains locked away in paper archives, it is hard for us to explore ways to leverage this knowledge while protecting confidential commercial information,” said Dr. Scott Gottlieb, FDA’s Deputy Commissioner for Scientific and Medical Affairs. “Receiving information in a consistent electronic format would help FDA make more effective use of important drug information especially in safety situations.”
Today’s announcement follows numerous steps taken by the agency over the past ten years to transform all regulatory submissions from paper to electronic means. To meet this goal, FDA has issued regulations enabling voluntary electronic submission of regulatory information; provided a docket listing all submissions that the agency accepts electronically; and issued guidance documents to assist in the submission of various regulatory documents in electronic format.
The scope of the upcoming hearing will include the following issues related to an all-electronic environment.
feasibility issues related to the electronic submission of premarket submissions and other regulatory information; and
issues related to the concept and feasibility of an electronic platform that would facilitate the exchange of clinical research information and other regulatory product information, the role of a public/private partnership helping the creation and assessment of such an electronic platform, and the management of the platform after its creation by a private entity with the relevant technological expertise.