A major part of the National Eye Institute?s mission is to support the translation of basic research discoveries into products and services to prevent and treat blindness and vision loss. One of the programs in the NEI extramural grant portfolio, the Small Business Grant Program, provides funding for companies to convert innovative ideas into real products that help people. The program has three phases. The first provides funding for companies to establish proof of concept, or to develop a prototype. The second phase funds the development of an actual product that is safe and effective. In the third phase, companies come up with their own financing to commercialize their product or service. Many of the companies are developing drugs or medical devices that require regulatory approval from the Food and Drug Administration. This is a major hurdle for these small companies, most of which don?t have any experience navigating the treacherous waters of the FDA approval process. To improve the success rate of the companies funded through the Small Business Grant Program, the NEI will be starting a new regulatory assistance program. Companies that are selected will receive 30 hours of high quality regulatory consulting, provided by a well-established regulatory consulting firm, to assist them in developing a step-by-step plan for receiving FDA approval. Close collaboration with an established program at another Institute has allowed the NEI to benefit from their experience in rolling out the program and to save time and costs. The NEI is optimistic that this program will speed up the process, and improve the success rate, of the companies who are developing ophthalmic drugs and devices to treat the blind and visually impaired.
