Connecting Awardees with Regulatory Experts (CARE): NCI and NHLBI is making progress to support FDA interaction.

The CARE program is an innovative collaboration between the National Cancer Institute (NCI) and Food and Drug Administration (FDA) that provides invaluable support to small businesses developing potential technologies under FDA regulatory authority. Through the CARE program, small businesses are connected with the FDA and receive support in communications during early stage product development. This program is designed to help small businesses navigate the complexities of the FDA and ensure that their products are developed in accordance with FDA regulations.

The CARE program 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.

The CARE program provides a valuable opportunity for small businesses to access the expertise of the FDA and ensure that their products are developed in accordance with FDA regulations. Through the CARE program, small businesses have access to resources and support that can help them navigate the complexities of the FDA and ensure that their products are developed in a safe and effective manner.

If you are an NCI or NHLBI-funded small business looking to develop a product under the regulatory authority of the FDA, the CARE program is an invaluable resource that can help you navigate the complexities of the FDA and ensure that your product is developed in accordance with FDA regulations. For more information, NCI-funded companies can contact Monique Pond (monique.pond@nih.gov), and NHLBI-funded companies can contact Joe O’Connor (joseph.oconnor@nih.gov) to learn more about the CARE program and determine if your company is eligible.

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