CDER Patient-Focused Drug Development  Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics On September 28, 2021, FDA is holding a virtual public workshop with the Reagan-Udall Foundation for the FDA to share lessons learned from the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly known as Operation Warp Speed) to bring relevant therapeutics to use in a public health emergency. Individuals and organizations may submit comments on this public workshop by December 28, 2021 through the public docket. To register for the workshop, and for more information, please click here. Critical Path Institute (C-PATH) Hosts 2021 Rare Disease Cures Accelerator-Data Analytics Platform (RDCA-DAP) Workshop On September 14, 2021, C-PATH hosted the 2021 RDCA-DAP Workshop. The RDCA-DAP® is an FDA-funded initiative with the goal of accelerating therapy development across rare diseases. The platform serves as a centralized and standardized infrastructure to host and share rare diseases data, to support and accelerate rare disease innovation. The purpose of the workshop was to: - Introduce and demonstrate the platform for the first time
- Case studies will show the usability, diverse functionality and interface to analytical tools
- How to access data now and in the future
- Build upon stakeholder engagement and engage academic, clinical and patient communities
- Understand roles stakeholders play in the success of RDCA-DAP
- Increase and influence data standardization and data sharing
The workshop recording is now available. To view the workshop recording and materials, please click here. For more information on the 2021 RDCA-DAP Workshop, please click here. | 
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