Radiopharmaceuticals
Notice of Intent: Regulations Amending the Food and Drug Regulations regarding the Drug Identification Number (DIN) Requirements for Schedule C Drugs (Radiopharmaceuticals)
Date: 2007-07-28
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Draft Guidance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
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