Radiopharmaceuticals

• Regulations Amending the Food and Drug Regulations (Positron-emiting Radiopharmaceuticals) - Project 1561
  Date: 2009-03-23
• Guidance Document: Factors Considered in the Assessment of Risks Involved in the Use of Positron Emitting Radiopharmaceuticals in Basic Research Involving Humans
  Date: 2006-02-27
• Guidance Policy: Use of Positron Emitting Radiopharmaceuticals in Basic Research Involving Humans
  Date: 2006-02-27
• Annex to the Good Manufacturing Practices Guidelines - Good Manufacturing Practices (GMP) for Positiron Emitting Radiopharmaceuticals (PERs)
  Date: 2006-02-02
• Stability Testing of Existing Drug Substances and Products
  Date: 2003-06-10
• Draft Quality Information Summary - Radiopharmaceuticals (QIS-R)
  Date: 2001-08-01
• Draft Guidance for Industry, Preparation of the Quality Information for Radiopharmaceuticals (Schedule C Drugs) using the Quality Information Summary-Radiopharmaceuticals (QIS-R) and Certified Product Information Document- Radiopharmceuticals (CPID-R) Templates
  Date: 2001-08-01
• Stereochemical Issues in Chiral Drug Development
  Date: 2000-02-14