Funding Mechanisms: Fast-Track-SBIR, Fast-Track -STTR and Fast-Track -R61/R33
Purpose: This new NIDCR program seeks to accelerate the clinical translation of novel biomaterials for dental, oral, and craniofacial (DOC) applications through development and implementation of advanced data-driven tools designed to overcome critical bottlenecks in research and development (R&D) cycles that lead to delays in regulatory evaluations and translation to human use. A primary focus of this initiative is the acceleration of R&D cycles and the regulatory evaluation of novel and/or repurposed biomaterial formulations with unique functional properties optimized for the restoration, repair, or replacement of DOC tissues. The framework of the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Medical Device Development Tools (MDDT) program will be leveraged by this initiative as an innovative and important roadmap to guide the development of data-driven tools that are qualified by the FDA for a specific Context of Use (CoU).
Pre-Application Webinar: September 15th, 1:00 - 2:30 pm (EDT) - NIDCR and FDA staff members will provide technical assistance to potential applicants by explaining the goals and objectives of these three RFAs.
Webinar Registration: NIDCR Technical Assistance Webinar.
Participation in the webinar is optional and is not required for application submission in response to these FOAs. Attendees will be able to ask questions during the webinar and are encouraged to submit questions in advance to: NIDCR-FOA-Questions@nih.gov.
The webinar recording will be posted on the NIDCR website and provided to participants approximately one week after the event.