No Objection Letter

Ms. Erin J. Cunninghmm
Regulatory Compliance Associate
American College of R.adiol.ogy,
Radiation Therapy Onrology Group
18 18 Market Street, Suite 1600
PHILADELPHIA,Pennsylvania
USA 19103
(215) 717-0831
No Objection Letter RE: Protocol # RTOG 0233
Dear Ms , Cunninghm.:
K am pleased to :inform you that the information and material to support your
Clinical Trial Applioatian fi~rCISPLATIN / P A C L I T D L / FLUOROURACIL 1
GEMCITABINE, control number 122476, received on June 6,2008, have been reviewed and
we have no objection to your proposed study.
I would remind you of the necessity of complying with the Food and Drug
Regulcrlions, Division 5 , in the sale of t h i ~product for clinical testing. h addition, the regulations
impose record keeping responsibilities on thse conducting clinical trials.
You me dso rnrlinded that all clinical trials should be conducted in compliance with
the Therapeutic Products Directorate's Guidelinefor Good Clinical Practice.
Should you have any questions concerning this letter, please contact the Office of
Cljnical Trials (613) 941-21 32.
Yours sincerely,
,I?
C . Lourenco, Ph.D.
Manager - Clinical Trials Group 1
Office ofClinical Trials
Jun 12 2008
TPD - OCT
1*1
Health
Canada
13 :05
P. 01
Santi
Canada
Health Producb and Food Eranch
Direction gbnirale des produiQ dle rant&e t dles aliments
Direction des produits thbrapeutiques
Therapeutic Products Directorate
OUR MISSION: We contribute 1;o the hea1.h of
Canadians and to the effectiveness of the health cart
system by regulating pharmaceuticals a:ndmedical
devices and by providing Camdime filth access to
infomtion to make informed choicce.
I
NOTRE MISSION : Nous contribuons i l'arn6Iioration de Ia santC des
c&iens et g l'effjcacitddu syst;me de soins de eanrd en
n5glementanr lcs produits phmmceutiquee et lcs materiels mkdicaux el
en offcant aux Canadlens un accts A l'infcmation pour qu'ils pukscnl
hire dcs choix 6clairbs
IC you receive this fax in error, please advise the sender immediately.
SB vous recevez cetfe t6lkcopfe par erreur, veuillez en aviser immediatement lYenp4diteur.
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Erin J. CunnlngRam
Namchdom:
Orgr~lzation/Organismc;
D m : June 12: 2008
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Amcricm College of Radiology I Rdiatioil Rerapy Oncolagy Group
No. of Pages, incllrdibg tthispagdNPle pages, ihtluant ccttc p a p :
Building
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M a m g r - Clinical Trials G a u p I / Gestioiineifr: - RDmnlme des essais cliniques Oroupc I
Office ofClinicd Trials I Bureau dcs cssaie clinjquee
THERAPEUTIC PRODUCTS DIRECTORATE 1
DIIUCTION DES PRODUlTS TH~RAPEUTIQUES
HoIland Cmu, lowcr B,Subfloor I 5 ibnx &age Hbllwd Cross, Tour B
1600 S-ott ShsetJ1600 Ruc Scon
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MESSAGE
LNIPOIRTANT:
Before submitting an app1icatian pleael; ensure that your CD is In a CD Jewel Caselhard plaetic CD cage. The case is required
for storing the CD appropriately. I Ava.nt de soornettre votre demande, veuillez voue asssurer que votre CD est insh-4 dans un
Btui rilgide en plastique. L1itul egt ndfessraire afin de conserver le CD en bon ttat,
I
Releare of Protocol Safety and Efficacv Assessment Terndate-Clinical Trial A ~ ~ l k a t i g(PSEAT-CTAU
n
Diffusion du Madele d'kaluatie&
lI'iunocuit4st de l'efficsci~den urobcoles Demande d'essai clinluue (MEIFF-DEQ
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