It was a long time coming. But, finally, on December 17, 2014, the FDA announced that applications must be submitted electronically, and that submissions will be required to contain study data in conformance with CDISC standards.

The industry has been given 24 months from the publication of the final guidance documents to comply. Not wanting to waste any precious time, Pinnacle 21 hosted two webinars — on January 7th and 8th, 2015 — to help guide you through the new processes.

Dhananjay (DJ) Chhatre and Sergiy Sirichenko, both of whom currently support the FDA’s eDATA team, presented the critical material. DJ, a former FDA operations research analyst, provided attendees with an overview of the final guidance documents, as well as a tutorial on planning and providing standardized study data to the FDA. Sergiy, the co-founder of OpenCDISC, guided attendees through the technical implementation of the new FDA requirements.

According to the final guidance documents, the FDA may refuse to file (RTF) any submission that isn’t received in electronic form and/or doesn’t conform to the required FDA study data standards, formats, and terminologies. This is a critical and timely mandate. But, worry not: we’re here to guide you through it.

Below, you’ll find links to the webinar video and corresponding PPT decks, as well as the Q&A that followed. And, if you have any specific questions pertaining to the new FDA study data standards, don’t hesitate to
send us an email.

Webinar Takeaways:

• Watch the webinar video
• Read the webinar Q&A
• Download the webinar slides
  FDA Guidance Overview, Planning, and Communications
  Technical Implementation of FDA requirements