| Call Number | 17192 |
|---|---|
| Day & Time Location |
R 2:30pm-5:20pm To be announced |
| Points | 3 |
| Grading Mode | Standard |
| Approvals Required | None |
| Instructor | Robert Mac Arthur |
| Type | LECTURE |
| Method of Instruction | In-Person |
| Course Description | This course will provide an introduction to the US Food and Drug Administration (FDA) and the drug development and approval process, often referred to as the “Critical Path”. The class will begin with a review of the history and organization of the FDA, and analysis of the principle steps along the critical path, including preclinical testing, clinical testing (drug development phase 0 thru IV), Good Laboratory Practices, Good Manufacturing Practices, Good Clinical Practices, and adverse event reporting. Different types of FDA submissions (IND, NDA, ANDA, SPA, eCTD), and FDA meetings will be examined, along with accelerated drug approval strategies, orphan drug development strategies, generic drug development, and post-marketing Sponsor commitments. Throughout the class we will study the related legislation and regulations that empower FDA, and the interrelated FDA guidance documents that define FDA expectations. |
| Web Site | Vergil |
| Department | Biostatistics |
| Enrollment | 24 students (25 max) as of 8:05PM Thursday, January 2, 2025 |
| Subject | Biostatistics |
| Number | P6170 |
| Section | 001 |
| Division | School of Public Health |
| Open To | GSAS, Public Health |
| Section key | 20241BIST6170P001 |