Authors: Kavade Shirisha, K. Someshwar
Abstract: Combination products, which are a new class of treatments that present difficult regulatory issues, are made up of a combination of medications, devices, and/or biological products. The United States Food and Drug Administration's (USFDA) regulatory framework for the categorization, approval, and supervision of combination products is examined in this thesis. Key provisions under 21 CFR Part 3 are highlighted, along with the Office of Combination Products' (OCP) function, the principal mode of action (PMOA) determination procedure, and premarket submission paths such as NDA, BLA, and PMA/510(k). To demonstrate how recommendations are applied in practical situations, case studies and regulatory precedents are examined. In order to expedite product development and guarantee compliance, the study emphasizes the significance of interdisciplinary cooperation and early regulatory engagement.
DOI: http://doi.org/10.5281/zenodo.20440187
