This course reviews federal Food and Drug Administration theory and practice, with a particular emphasis on product labeling requirements and the new drug approval process. The course reviews the requirements for preclinical studies, the three phases of clinical investigation, and the conduct of post marketing surveillance. IND and IDE requirements are studies. The “substantial evidence” necessary to support approval of a NDA, ANDA and SNDA are explored.
Syllabus: The current course syllabus is available to enrolled students only.