FDA Draft Controls Guidance: A Roundtable Discussion
Please join C-Path and the Clinical Research Data Sharing Alliance (CRDSA) on Wednesday, July 19, at from 10:00 a.m. to noon EDT for a roundtable discussion about the recent FDA draft external controls guidance. The webinar will convene panelists that includes C-Path’s Shu Chin Ma and Jagdeep Podichetty, as well as others from industry, academic institutions, and patient advocacy groups to examine critical questions such as:
- Why is regulatory acceptance of alternative control design essential to patients and society?
- What key issues must be addressed to create a viable regulatory pathway?
- How can the community support the FDA in developing guidance that supports the expanded use of alternative control trial designs?
We will also welcome audience participation in a Q&A session. Join the conversation and take part in this important step in FDA guidance development.