Jump to content
The " Regulatory Guidance : Introduction " course is 1 of 18 courses included in the Introduction to Immuno-Safety Science Module.
This course is lead by Dr. David McMillan PhD; a toxicologist at the United States Food and Drug Administration (US FDA).
- Provide a brief history and timeline of guidance documents
Describe the importance and application of various guidances documents (broad overview) in drug development (more detail to be provided in the Regulatory module and HESI resource documents)