No Objection Letter

TPII - OCT
Health
Canada
Fax :6139467996
Rug
I 2008 13:53
P. 02
Therapeutic Products Directorate
5th Floor, Holland Cross, Tower B
Addrese Locator# 3105A
Sante
Canada
OTTAWA, Ontario
KlAOK9
a
1 August 2008
Ms,Erin J. Cunningham
Regulatory Compliance Associate
American College of Radiology,
Radiation Therapy Ollcology Group
18 18 Market Street, Suite 1600
PHILADELPHIA, Pennsylvania
USA 19103
(215) 717-0831
No Objection Letter RE:Amendment # 3 to Protocol # RTOG 0424
Dear Ms.Cunningham:
This is to advise you that the data concerning your Clinical Trial Application for
TEMOZOEOMIDE, mntrol numbs 123346 which were received on July 10, 2008, have been
reviewed and we have no objection to the amendment to the study. Please note that a new
control number has been assigned to this Clinical Trial Application Amendment only. Any
correspondence relating to the original CTA should be referenced to the original control number
assigned,
I would remind you of the necessity of complying with the Food and Drug
Regulations, Division 5 , in the sale of this product for clinical testing. You are also reminded
that all clinical trials should be conducted in compliance with the Therapeutic Products
Directorate's Guideline for Good Clinical Practice.
Should you have any questions concerning this letter, please contact the Office of
Clinical Trials at (61 3) 941-2132.
.
,
Yours sincerely,
/
C,Laurence, P h D
Manager - Clinical Trials Group I
Office of Clinical Trials
TPD
-
OCT
1+1 Health
Canada
Rug
1 2008
13:53
P. 01
Sante
Canada
Health Products and Food Branch
Direction generale des produits de $ante et des aliments
Therapeutic Products Directorate
Direction des produits th6rapeutiques
OUR MISSION: We contribute to the hcalth of
Canadians and to the effectivmess of the health care
NOTRE MISSION ; Nous contribuons il l'm8li~rationde la sanb5 des
Canadiens et t~I'efficaacit du systeme de soins de sante en
reglernentant les pmduits pharmaceutiques et lcs mat6riels mddicaux et
en o f h t wx Canediens un acces i~l'infmation pour qu'ils puissent
faire des choix tclairQ
system by regulating pharmaceuticals md medical
devices wd by providing Canadians with access to
information to make informed choices.
--
-
H you recefve this fax in error, please advise the sender immediately.
Si vow recevez cette t8lbcopfe par erreur, veuillex en aviser immddiatement l'expbditeur.
- -. -Warnc/Nom:
Erin J. Cunningham
Or~anizationlOrgnnisme:
American Collcgc olRadiolow I Miation Thaapy -logy
h
Dak August 1,2008
p
2
No, of Pages, including thie p n g m dc p g a , inoluant cottc page:
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Buiiding
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M a n w r Cliniml Trials Group I / Gestlonnaire Pmpamme des essais cliniques Oroupo I
Officc dclinicol Trials I Bu:csr: des essais cliniqucs
THERAPEUTIC PRODUCTS DIRBCTORATE /
DIKECTON DES PRODUITS ~ ~ E u T I Q L J E s
liolland Crore, Tower 6,S" floor I5 ibmt C t s Holland
~
Croa, Tour B
1600 Scott S e e V 1600 Ruc Scott
Lacoror
3105A
OTTAWA, Onrnrio
K I A OK9
CiLyProvincc
Postal Code
TITRE
Dlvisio~~
Dimtion
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Locelirateur d'adwrrsc
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Websitdsite Web : http:llwwwhc-sc,gc.ca/dhp-mpslpmdphamdindex-e.hmY
,
http:/lww.hc-sc.~c.ca/dhp-mp&'prodphdxfhtml
MESSAGE
IMPORTANT:
Before submitting aa epplicatlon please ensure that your CD is in a CD Jewel Casehard plastic CD case, The case is required
for storing the CD appropriately. I Avant de sournettre votre demande, veuillez vous asssurer que votre CD lest inbrk dams un
Ctui riglde en plastiqne. L'ktui est n l ~ e a a i r eafin de conserver le CD en bon Itat.
h.,
Cllnlarl Trla
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Diffusion du Mod& d'evabation dle I'innocult8 et de l'efficacite des motd'essal clinlaue WIEP-DEC)
http:i/~.hc-sc.gc.ca/dhp-mps/prodp~our/index_e.hrm
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