CARE Regulatory Program
The CARE program is an interagency collaboration between the National Cancer Institute (NCI) and Food and Drug Administration (FDA). The goal of the program is to connect small businesses with the FDA and support communications during early stage product development.
Eligibility is open to NCI SBIR/STTR-funded small businesses that are developing potential technologies under the regulatory authority of FDA, including the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. In addition, the program is open to NHLBI SBIR/STTR-funded small businesses that are developing potential technologies under the regulatory authority of the Center for Devices and Radiological Health. This program is intended for early stage companies that have not discussed their technology with FDA or participated in the CARE program previously.
To learn more about the history of the CARE program, please read our mini review in Clinical and Translational Science.