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98D-0266: Section 121 Positron Emission Tomography (PET)
Item Code
No.
Received Date
Submitter
Signature
FR Date
FR Page
PDF ID
(size in kb)
Text ID
(size in kb)
SUP 2 02/17/99 Supplements to Agenda 2/18/99       sup0002.pdf (343)  
TR 3 03/18/99 Institute for Clinical Pet/CDER 2/19/99         tr00003.doc (531)
TR 2 03/18/99 Institute for Clinical Pet/CDER 2/18/99         tr00002.doc
(466)
LST 1 2/16/99 Agenda of Meeting Between the Institute for Clinical PET and FDA Staff         lst0001.wpd (5)
      F-18 FDG PET in Oncology: Safety & Effectiveness Review Florence Houn MD, MPH       lst001a.ppt (417)
      Model Application to Manufacture Fludeoxyglucose F 18 Injection         lst001b.wpd (53)
      Letter to Institute for Clinical PET Jane A. Axelrad       lst001c.wpd (28)
      Outline of Existing Regulatory Framework for New Drugs           lst001d.wpd (5)
      Draft Outline for Positron Emission Tomography (PET) GMPs         lst001e.doc (89)
      Existing Regulatory Framework for Drug Approval         lst001f.wpd (50)
M 1 2/9/99 HFD-160 Kim Marie Colangelo       m000001.doc (20)
MT 1 1/19/99 HFD-5 & Institute for Clinical PET Jane Axelrad & Kim Colangelo     mt00001.pdf (38) mt00001.doc (37)
Tr 1 12/17/98 Institute for Clinical Pet / CDER       tr00001.pdf (15,040)  
C 3 12/07/98 University Hospital Dept. of Nuclear Medicine Edward B. Silberstein MD     c000003.pdf (270)  
LET 3 11/18/98 HFD-6 & UCLA School of Medicine Jane A. Axelrad     let0003.pdf (75)  
MM 1 10/29/98 HFD-6 & Institute for Clinical PET Repre       mm00001.doc (28)  
C 2 8/27/98 University of California, Los Angeles Jorge R Barrio PhD  
 
 
  
c000002.pdf (535)   
LET 2 8/13/98 HFD-5 to UCLA School of Medicine Jane A Axelrad  
  let0002.pdf (167)  
LET 1 8/13/98 HFD-354 to US Pharmacopeia Yana Ruth Mille  
 
let0001.pdf (1,370)  
N 1
 
 
 
7/30/98 40719 n000001a.pdf (4pgs)   

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