Clinical Trial Applications for Biologics and Radiopharmaceuticals
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.
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
Data and Resources
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