BIOT2300

Description

The course will explore the regulations and requirement of new product filing process by which the FDA has used successfully to safe guard the public interest from novel therapeutic drug products. Some of the key steps by which life science and pharmaceutical companies used to assemble their product development data on discovery, preclinical studies, CMC process, and clinical studies for FDA filing will be examined. This course will show the students the important process of regulatory filing for new drug development so that students may appreciate the extensive product development hurdles, documentation, validation, and quality control of every step to assure a successful filing. Although the course will focus on the known regulatory platforms in small molecule and biologic filings, some discussion on the new fields of cell and gene therapies will be compared and contrasted with the established filing platforms.