Description
Clinical Trial Applications for pharmaceutical (Schedule F), radiopharmaceutical (Schedule C) and biological (Schedule D) drugs are all regulated under Part C, Division 5 of the Food and Drug Regulations, and therefore all must adhere to the same regulatory requirements. However, biological drugs carry additional risks associated with complexity and variability in manufacturing.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Clinical Trial Applications for Biologics and Radiopharmaceuticals | HTML | Open resource | |
| Clinical Trial Applications for Biologics and Radiopharmaceuticals | HTML | Open resource |