CDISC Blog

FDA Presentation at the CDISC European Interchange We were very fortunate to have Dr. Chuck Cooper, FDA/CDER, join us at the CDISC European Interchange last month! (Mary Ann Slack, also of FDA, had also planned to present in this session; however, she was unable to travel to Stockholm at the last minute. Dr. Cooper combined her slides with his and spoke for both of them.) As the E3C Chair, Pierre-Yves Lastic, commented…the attendees were very pleased to have an FDA representative there ‘in flesh and blood’ to talk with them and answer their questions.

Dr. Cooper’s slides will be made available to the Interchange attendees, but here are a few highlights/quotes for those who were unable to attend:

The electronic format and standards are critical for FDA.

“We cannot improve efficiency or innovate without standards."

We want to improve regulatory decision-making through better access to structured scientific data.

Non-standard electronic data limits quality and efficiency during the review process.

PDUFA V is coming; PDUFA IV ends in late September 2012. The FDA is building a clinical trial repository (CTR), formerly called Janus, which is BRIDG-informed and is receiving input from the division data standards heads and clinical and statistical reviewers. They are using an OpenCDISC enterprise tool and will eventually share their validation checks.

The vision at FDA is a ‘standards-based end-to-end fully electronic review environment’.

By Dr. Rebecca Kush

CDISC, President and CEO