FDA Regulation and Product Development.

Catalog description

Overview of the medical device path to market with emphasis on regulatory strategy in a highly regulated global environment. Topics include development of regulatory pathways, implementation of Good Laboratory Practices (GLP) for preclinical studies, and Good Clinical Practices (GCP) for clinical trials in accordance with FDA regulations. Similarities and differences between GLP and GCP are examined in the context of introducing new drugs and medical devices. PreReq: None.