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Products and the Draft Guidance on CGMP for PET Drug Products
DATE AND TIME: May 21, 2002, from 9 a.m. to 4:30 p.m.
LOCATION: Room 1066, 5630 Fishers Lane, Rockville, MD.
A discussion between representatives of the Academy of Molecular Imaging and FDA on the preliminary draft proposed rule on Current Good Manufacturing Practice for Positron Emission Tomography Products and the draft guidance entitled "PET Drug Products - Current Good Manufacturing Practice (CGMP)." The discussion was open to the public, with time allotted for public comment on the discussion topics. Pre-registration was not necessary to attend this meeting.
See the Federal Register Notices of April 1, 2002, for more details:
- Proposed Rule Federal Register Notice [Text], [PDF]
- Guidance Federal Register Notice [Text], [PDF]
- Presentation: FDA Approach to PET CGMP, Brian Pendleton, J.D. May 21, 2002
- Transcripts (WORD)
(3/18/2003)
