RGA 6465 — Nonclinical Regulations in Biomedical Product Commercialization
2 semester hoursGraduateLecture
Examines the nonclinical regulatory processes involved in commercializing biomedical products within the U.S. Food and Drug Administration's CBER, CDER, and CDRH. Offers students an opportunity to conduct a comprehensive analysis of FDA's quality standards for biomedical products, including gene and cellular-based therapies, with respect to ICH Common Technical Document Module 4. Presents an overview of preclinical investigational new drug requirements and good manufacturing practice regulations that must be fulfilled by biomedical product manufacturers in support of CTD Module 3. Studies biocompatibility testing requirements for medical devices according to FDA guidance and ISO 10993 standards to support 510(k) and PMA submissions.