ML20057F789
| ML20057F789 | |
| Person / Time | |
|---|---|
| Issue date: | 09/22/1993 |
| From: | Surmeier J NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | GENERAL |
| Shared Package | |
| ML20057F790 | List: |
| References | |
| NUDOCS 9310190124 | |
| Download: ML20057F789 (10) | |
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UNITED STATES NUCLEAR REGULATORY COMMISSION
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wAssincrow, o.c. rossmi September 22, 1993 ALL AGREEMENT STATES TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-93-119)
Your attention is invited to the attached correspondence which contains*
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INCIDENT AND EVENT INFORMATION.......
l PROGRAM MANAGEMENT INFORMATION.......
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l TRAINING COURSE INFORMATION..........
TECHNICAL INFORMATION................XX PRODUCT LICENSE I
APPROVAL fPLA) l OTHER INFORMATION....................
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Supplementary information:
Attached is an NRC memorandum on the l
use of Product License Approval (PLA) drugs.
Oncoscint CR/OV, a 4
product manufactured by Cytogen Corporation, is a cancer imaging agent that has received a PLA from the Food and Drug Administration (FDA).
Also, included for your information are several documents related to the licensing of cytogen in the Agreement States, an Oncoscint CR/OV product insert and the
" card" describing Cytogen's approval under the authority of the Illinois Department of Nuclear Safety.
If you have further questions regarding this corresponcence, please contact the individual named below.
1 POINT OF CONTACT:
Jim Myers l
TELEPHONE:
(301) 504-2328 l
FAX 301) 04-3502 j
s Joh J. Surmeier, Acting Assistant Director l
for State Agreements Program Office of State Programs
Enclosures:
As stated l
9310190124 930922 PDR STPRG ESCGEN
[01 PDR
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Enclosures:
As stated (SP-93-119) f
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Oncoscint product insert l
NRC memorandum dtd August 6, 1993 l
Cytogen letter dtd March 30, 1993 Cytogen ~ letter dtd August 12, 1993 Georgia DNR, RAM Program Bulletin No. 93-02, dtd April 13, 1993 Georgia memorandum.dtd April 13, 1993 Georgia Radioactive Materials Licenses Washington Dept of Health memorandum dtd April 7, 1993
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