From: Walsh, Maria R
Sent: Tuesday, November 02, 2004 2:29 PM
To: Butler, Jennie C
Subject: FW: Radioactive Drugs for Certain Research Uses -- Public
Meeting (November 16) Docket No. 2004N-0432

Jennie,

Final presentation attached.

Maria

-----Original Message-----
From: Maynard Ken [mailto:KMAYNARD@snm.org] 
Sent: Tuesday, November 02, 2004 2:23 PM
To: Walsh, Maria R
Cc: Cannon Hugh C.
Subject: RE: Radioactive Drugs for Certain Research Uses -- Public Meeting (November 16) Docket No. 2004N-0432

Dear Ms. Walsh:
Attached please find Dr. Gelfands powerpoint slides for his RDRC presentation re peds issues on 11/16.

Ken

Ken Maynard
Associate Director - Public Affairs
Society of Nuclear Medicine
1850 Samuel Morse Drive
Reston, VA 20190
Direct:  703.326.1187      Fax:  703.708.9777
Email: kmaynard@snm.org 

-----Original Message-----
From: Maynard Ken 
Sent: Tuesday, November 02, 2004 2:22 PM
To: 'Walsh, Maria R'
Cc: Cannon Hugh C.
Subject: RE: Radioactive Drugs for Certain Research Uses -- Public Meeting (November 16) Docket No. 2004N-0432

Dear Ms. Walsh:
Attached please find Dr. Thakur's RDRC 11/16 powerpoint slides for his RDRC Membership comments.  

Ken

Ken Maynard
Associate Director - Public Affairs
Society of Nuclear Medicine
1850 Samuel Morse Drive
Reston, VA 20190
Direct:  703.326.1187      Fax:  703.708.9777
Email: kmaynard@snm.org 

-----Original Message-----
From: Maynard Ken 
Sent: Tuesday, November 02, 2004 2:21 PM
To: 'Walsh, Maria R'
Cc: Cannon Hugh C.
Subject: RE: Radioactive Drugs for Certain Research Uses -- Public Meeting (November 16) Docket No. 2004N-0432

Dear Ms. Walsh:  Attached please find the PowerPoint slides for Dr. Beven's RDRC presentation on 11/16/04.

Ken

Ken Maynard
Associate Director - Public Affairs
Society of Nuclear Medicine
1850 Samuel Morse Drive
Reston, VA 20190
Direct:  703.326.1187      Fax:  703.708.9777
Email: kmaynard@snm.org 

-----Original Message-----
From: Walsh, Maria R [mailto:WALSH@cder.fda.gov]
Sent: Tuesday, October 26, 2004 12:43 PM
To: Maynard Ken; Walsh, Maria R
Cc: Cannon Hugh C.
Subject: RE: Radioactive Drugs for Certain Research Uses -- Public Meeting (November 16) Docket No. 2004N-0432

Mr. Maynard and Mr. Cannon,

Dr. Thakur (pharmacological effects), Dr. Royal (radiation dose limits), and Dr. Gelfand (pediatric subjects) are scheduled to present at the November 16th RDRC public meeting during the 10:00 - 11:00 am public presentation session.

Dr. Thakur (RDRC membership), Dr. Royal (women of child-bearing potential), and Dr. Beven (RDRC membership) are scheduled to present during the 2:45 - 4:00 pm public presentation session.

The presenters names will appear on the agenda as follows:

	Henry D. Royal, MD, University of St. Louis,Mallinckrodt Institute of Radiology
	Mathew L. Thakur, PhD, Society of Nuclear Medicine
	Terence Beven, PhD, FACNP, American College of Nuclear Physicians

	Michael J. Gelfand, MD, Children's Hospital, Cincinnati, Ohio	

Please let me know if you have any edits by close of business November 1, 2004.

Thank you.

Maria

Maria R. Walsh, RN, MS
Project Management Officer

FDA/CDER/OND
Office of Drug Evaluation III Immediate Office (HFD-103)
5600 Fishers Lane
Rockville, Maryland 20857
Phone: (301) 827-3139
Fax: (301) 480-3761
e-mail: walsh@cder.fda.gov 

-----Original Message-----
From: Maynard Ken [mailto:KMAYNARD@snm.org] 
Sent: Wednesday, October 20, 2004 11:12 AM
To: walsh@cder.fda.gov
Cc: Maynard Ken; Cannon Hugh C.
Subject: FW: Radioactive Drugs for Certain Research Uses -- Public Meeting (November 16) Docket No. 2004N-0432

The message below bounced back from our file server overnight with the message of "...recipient server full."  Could you please acknowledge receipt of this once received?  I'm also sending a duplicate copy by fax.  Many thanks. Ken Maynard

Ken Maynard
Associate Director - Public Affairs
Society of Nuclear Medicine
1850 Samuel Morse Drive
Reston, VA 20190
Direct:  703.326.1187      Fax:  703.708.9777
Email: kmaynard@snm.org 

		 -----Original Message-----
		From: 	Maynard Ken  
		Sent:	Monday, October 19, 2004 2:14 PM
		To:	'walsh@cder.fda.gov'
		Subject: FW:Radioactive Drugs for Certain Research Uses --
Public Meeting (November 16)   Docket No. 2004N-0432

			As requested in the Federal Register Announcement,
and in follow-up to Hugh Cannon's email to you of Friday, 10/15/04, we would like to add the following individual to testify at the meeting:

			Pharmacology Issues
				Mathew L. Thakur - representing the Society
of Nuclear Medicine
				Thomas Jefferson University

				Department of Radiology
				1020 Locust Street, Rm.359 JAH
				Philadelphia, PA 19107
				Telephone:  (215) 503-7874
				E-mail:  Mathew.Thakur@ Jefferson.edu
				Dr. Thakur will discuss the pharmacological
effects of ingredients that are not endogenous, how an investigator can confirm that a radioactive drug causes no clinically detectable pharmacological effect in humans, and what parameters should be used to determine if a pharmacologic effect has occurred.
				He will speak for approximately 10 minutes.

Ken Maynard
Associate Director - Public Affairs
Society of Nuclear Medicine
1850 Samuel Morse Drive
Reston, VA 20190
Direct:  703.326.1187      Fax:  703.708.9777
Email: kmaynard@snm.org 

> 	 -----Original Message-----
> 	From: 	Cannon Hugh C.  
> 	Sent:	Friday, October 15, 2004 4:24 PM
> 	To:	'walsh@cder.fda.gov'
> 	Subject:	Radioactive Drugs for Certain Research Uses --
Public Meeting (November 16)   Docket No. 2004N-0432
> 
> 		As requested in the Federal Register Announcement the
following 
> individuals intend to testify at the meeting:
> 
> 		Radiation Dose Limits for Adult Subjects:
> 			Henry D. Royal, MD - representing the University of
St. Louis
> 			Mallinckrodt Institute of Radiology		
> 			Division of Nuclear Medicine
> 			510 South Kingshighway
> 			St. Louis, MO 63110
> 			Telephone Number:  (314) 362-2809	
> 			E-mail:  RoyalH@mir.wustl.edu
<mailto:RoyalH@mir.wustl.edu>
> 			Dr. Royal will discuss present dose limits and their
appropriateness for different age groups in light
> 			of the scientific knowledge advancements since 1975.
> 			His presentation will take approximately 10 minutes.
> 
> 		Assurance of Safety for Pediatric Subjects 
> 			Michael J. Gelfand. MD - representing Children> '> s
Hospital
> 			Children> '> s Hospital
> 			519 Chisholm Trail
> 			Cincinnati, OH 45215
> 			Telephone: (513) 636-7650
> 			E-mail:  Michael.gelfand@cchmc.org
<mailto:Michael.gelfand@cchmc.org>
> 			Dr. Gelfand will address the safeguards for
pediatric subjects provided by 361.1 and their
> 			adequacy ensuring no significant risks for pediatric
subjects.
> 			His presentation will take approximately 10 minutes.
> 
> 		Exclusion of Pregnant Women
> 			Henry D. Royal, MD - representing the University of
St. Louis
> 			Mallinckrodt Institute of Radiology
> 			Division of Nuclear Medicine
> 			510 South Kingshighway
> 			St. Louis, MO 63110	
> 			Telephone: (314) 362-2809
> 			E-mail:  RoyalH@mir.wustl.edu
<mailto:RoyalH@mir.wustl.edu>
> 			Dr. Royal will discuss the assurances that should be
provided to guarantee each female subject
> 			of childbearing age participating in research
studies is not pregnant.
> 			His presentation will take approximately 10 minutes.
> 
> 		RDRC Membership
> 			Terence Beven, FACNP - representing the American
College of Nuclear Physicians
> 			Department of Nuclear Medicine> 
> 			Our Lady of The Lake Regional Medical Center
> 			5000 Hennessy Boulevard
> 			Baton Rouge, LA 70808
> 			Telephone:  (225) 765-8995
> 			E-mail:  tbeven1957@aol.com
<mailto:tbeven1957@aol.com>
> 			Dr. Beven will speak to the membership of the RDRC
and the process of > "> vetting> ">  new members.
> 			He will speak for approximately 10 minutes.

> 
> 			
> 
> 			
> 		RDRC Membership
> 			Mathew L. Thakur - representing the Society of
Nuclear Medicine
> 			Thomas Jefferson University			
> 			Department of Radiology
> 			1020 Locust Street, Rm.359 JAH
> 			Philadelphia, PA 19107
> 			Telephone:  (215) 503-7874
> 			E-mail:  Mathew.Thakur@ Jefferson.edu
> 			Dr. Thakur will discuss the value of diverse
expertise in structuring the RDRC in its work.
> 			He will speak for approximately 10 minutes.	
> 
> 			
> 
> 			
>