| Compliance >Key National and International Standards, Laws, Regulations, and Guidelines |
Information Concerning Positron Emission Tomography Drug Products and GMP
Positron Emission Tomography: Sample Template for Component Record Keeping [PDF] or [Word] (19 September 2005)
Good Manufacturing Practices Rule for Radioactive PET Drugs Proposed [HTML] [PDF] (15 September 2005)
Guidance for Industry: PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML] or [Word] or [PDF] (15 September 2005)
Food and Drug Administration Modernization Act, Sec 121. Positron Emission Tomography
Preliminary draft proposed rule for Current Good Manufacturing Practice for Positron Emission Tomography Drug Products, and a guideline to accompany it. (1 April 2002)
FDA’s Response to Issues Raised by the PET Community Regarding the 1999 Preliminary Draft Regulations on CGMP for PET Drugs [HTML] or [PDF] (5 April 2002)Meeting Transcript (WORD): Informal Discussion of the Preliminary Draft Proposed Rule on Current Good Manufacturing Practice (CGMP) for Positron Emission Tomography (PET) Drug Products and the Draft Guidance on CGMP for PET Drug Products. (21 May 2002, )
Presentation: FDA Approach to PET CGMP, Brian Pendleton, J.D. (21 May 2002)
Eleventh Annual Pet Conference, Vancouver, Canada (26 October 1999)
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Public Meeting, Gaithersburg, Maryland (28 September 1999)
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