Guidance Documents - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies

The following guidance documents have been prepared to assist in the interpretation of the policies governing statutes and regulations.

• Clinical Trials
• Cost Recovery
• Drug Interactions
• Drug Submission Status Requests
  • Drug Submission Status Requests: Biologics and Genetic Therapies Directorate
  • Drug Submission Status Requests: Therapeutic Products Directorate
• Drugs Currently Regulated as New Drugs
• Good Guidance Practices
• Guidance Document: Schedule A and Section 3 to the Food and Drugs Act
• Homeopathics
• ICH
• Management of Drug Submission
• Notice of Compliance with Conditions
• Official Methods
• Patented Medicines
• Post-Notice of Compliance (NOC) Changes
• Priority Review
• QT/QTc Interval Prolongation
• Reconsideration of Final Decisions
• Release of the finalized Guidance Document: Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice [2010-04-30]
• Subsequent Entry Biologics (SEBs)