Publications by authors named "Nobuo Uemura"
Purpose: The developer and sponsor of new cell-device and protein-device combination products in the United States needs to forecast which classification and designation to the regulatory scheme of biological products or devices would be required for the new products by the Food and Drug Administration (FDA). To improve the predictability and acceptability of the designation of new cell-device and protein-device combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization.
Methods: We searched the website of the FDA and the Alliance for Regenerative Medicine (ARM) on May 3, 2021 to identify the regulatory scheme of the FDA's capsular decision cases of cell-device and protein-device combination products, and of the tissue-engineered products approved by the FDA.
Objective: The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device would be required for the new products by the Food and Drug Administration (FDA). To improve the predictability and acceptability of the designation of new combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization.
Method: We searched the website of the FDA on 15 November, 2020 to identify the regulatory scheme of the FDA's 129 capsular decision cases of device-drug and device-biologics combination products and other publicly available cases the FDA designated to the drug/biologic or device regulatory scheme.