FDA Public Meeting on Transport Standards – 5 November 2012 On 5 November, the Food and Drug Administration (FDA) announced a meeting entitled “Regulatory New Drug Review: Solutions for Study Data Exchange Standards” with the purpose of soliciting input from industry, technology vendors, and other members of the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. The meeting was held at the FDA’s White Oak Campus in a large room with ~ 15 round tables, each seating 5-8 individuals (i.e. about 100 attendees). There were at least a dozen FDA representatives present, 5 with speaker/facilitator/presenter roles. This is simply a brief summary with the key points that came across to me, with a goal of reporting this objectively.
Mary Ann Slack (FDA, CDER OPI) opened the meeting reiterating the purpose to get industry input, objectively without debates. She said that they really wanted to have a discussion and that they will provide an e-mail address for thoughts that folks would like to send, even after the event. She cited some scenarios that will be placed on the FDA website to convey the ‘pressing challenges’ that FDA has with respect to receiving and reviewing data. Ms. Slack highlighted a few of the comments that were received in writing, including the need for high quality standards across the spectrum of research, recommendations including an end of Phase II data standards meeting for those developing new treatments and the need for more consistency---governance is key, she said.