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) |
|
