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Connecting Awardees with Regulatory Experts (CARE) Program

Apply to 2024 CARE Program

Application Deadline: Friday, March 8, 2024


The Connecting Awardees with Regulatory Experts (CARE) program is an interagency collaboration between the National Cancer Institute (NCI) and the Food and Drug Administration (FDA).  The goal of the program is to connect small businesses with the FDA and support communications with regulators early in the technology development process. 

To learn more about the history of the CARE program, please read our mini review in Clinical and Translational Science. 


The CARE program is open to SBIR/STTR awardees who have not participated in the CARE program previously or discussed their technology with any FDA centers, including the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH).

See the list below of participating NIH Institutes and their points of contact:


Point of Contact

National Cancer Institute (NCI)

Swamy Tripurani

National Heart, Lung, and Blood Institute (NHLBI)

Stephanie Davis

National Institute of Aging (NIA)

Rajesh Kumar

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Kari Ashmont

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Antonello Pileggi

NHLBI, NIA, NIBIB, and NICHD will only accept CARE applications for technologies regulated by CBER and CDRH. For more information, please get in touch with the point of contact listed above. 

Visit our Regulatory Resources page for curated links to key FDA guidance documents, regulatory education webinars, and point-of-contact information at each FDA center. These resources help small businesses navigate the complex regulatory landscape and better understand the regulatory requirements for various technologies.

Note: The CARE Program does not replace any formal or informal meetings that the FDA encourages or requires. 

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