Nonclinical Regulations in Biomedical Product Commercialization

Catalog description

Examines the nonclinical regulatory processes involved in commercializing biomedical products within FDA'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 (CTD) Module 4. Provides an overview of preclinical investigational new drug (IND) requirements and good manufacturing practice (GMP) regulations that must be fulfilled by biomedical product manufacturers in support of CTD Module 3. Additionally, offers students an opportunity to study biocompatibility testing requirements for medical devices according to FDA guidance and ISO 10993 standards to support 510(k) and PMA submissions.