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Connecting Awardees with Regulatory Experts (CARE) Program

 The application period is closed. Please check back for the next cycle.

 

Swamy Tripurani, Ph.D.

Contact Swamy Tripurani to learn more about this program.

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. 

Eligibility

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).

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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