K. MOUNIKA; T. SUDHEER KUMAR; R. KAMARAJ. A RETROSPECTIVE ANALYSIS OF US FDA BREAKTHROUGH DEVICES PROGRAM: SETTING A GLOBAL REGULATORY BENCHMARK. The Bioscan, [S. l.], v. 20, n. Special Issue-3, p. 1127–1136, 2025. DOI: 10.63001/tbs.2025.v20.i03.S.I(3).pp1127-1136. Disponível em: https://thebioscan.com/index.php/pub/article/view/4187. Acesso em: 29 dec. 2025.