On December 17th, the FDA made its long-awaited announcement: future submissions will be required in standardized format.

“ The Agency may Refuse To File (RTF) for NDAs and BLAs, or Refuse To Receive (RTR) for ANDAs an electronic submission that does not have study data in conformance to the required standards… ”  – FDA Guidance for Industry

This represents a seismic shift for the industry. However, adapting to this new paradigm can be relatively painless — if you have the right guidance.

Through this webinar, we’ll cover the details of the new mandate, what it all means, and the steps you’ll need to take. Our speakers are Dhananjay (DJ) Chhatre (former FDA operations research analyst) and Sergiy Sirichenko (co-founder of OpenCDISC): two industry experts who currently support the FDA’s eDATA team.

For your convenience, we’ll be providing this webinar at two different times.

In this webinar, we will cover:

• Descriptions of the final guidance documents and their contents
• How these new regulations will impact you
• FDA’s timeline for implementation
• How to communicate with the FDA during the process
• Technical implementation of CDISC standards
• Questions & Answers

Best regards.
OpenCDISC Team