Text

Advises That Local Radioactive Drug Research Committees Can Approve Projects Utilizing Uci Quantities of Radioactive Matl for Research Studies Only & Diagnostic & Therapeutic Studies Utilizing non-FDA Matl Approved by Fda
	ML19325D110
Person / Time
Issue date:	07/06/1988
From:	Nussbaumer D; NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA)
To:	Wong G; SACRAMENTO, CA
Shared Package
ML19325D099	List: ML19325D098; ML19325D109; ML19325D110; ML19325D126; ML19325D131; ML19325D143; ML19325D144; ML19325D151; ML19325D164; ML19325D180; ML19325D181;
References
	RULE-PRM-35-9 NUDOCS 8910190016
	Download: ML19325D110 (1)
	v • d • e

(b o

-(po"%

' i'

.[

NUCLEAR REGULATORY COMMISSION

-5 WASHINGTON,0 C.20596

~

5...a Ref:

St./LA3 41)(06Ig i

Gerard C. Wong, Ph.D., Chief J///, /

Radiation Management.Section i

/ fo4 Radiologic Health Branch State Department of Health Service

\\Qk'.

714 P Street, Office Building, #8 ii.-.:y-Sacramento, California 95814

Dear Dr. Wong:

This is in response to your April 15, 1988 letter regarding the extent of authority placed by the Food and Drug Administratico (FDA) to the i

i local Radioactive Drug Research Comittees (RDRC).

I am enclosing our memo to the NMSS group and their reply.

Basically, i

the RDRC can approve projects utilizing microcurie quantities of l

radioactive material for research studies only. Diagnostic and therapeutic studies utili:ing non-IND or NDA radioactive material may l

g h be approved by the FDA.

If you have any further questions please let us know.

l-Sincerely, I

h-&-f $

huense Donald A. Nussbaumer Assistant Director for l

u:

State Agreements Program State, Local and Indian Tribe Programs l

As stated i

l l:

Y I

8910190016 890605 PDR PRM 3S-09 PDR

. n

.-.wn-e

-a-<,

.,v--,,

---,,,a---we

-