No Objection Letter

TPD
-
May 28 2008 14 :57
OCT
P. 02
Therapeutic Products Directorate
5th Floor, Holland Cross, Tower B
Address Locator# 3105A
Health
Canada
OTTAWA, Ontario
KIA OK9
Your lila
Vare Ahfence
28 May 2008
Ms.Erin J. Cunningham
Regulatoty Compliance Associate
American Collage of Radiology,
Radiation Therapy On~ologyGroup
18 18 Market Street, Suite 1600
PHILADELPHIA,Pennsylxvania
USA 19103
(21 5) 717-0831
No Objection Letter RE: Protocol # RTOG 0822
Dear Ms. Cunninghaam:
I am pleased to inform you that the information and material to support your
Clinical Trial. Application jbr CAPECITAEINEIOXALIlPLATINl5-FLUOROKTMCILI
LEUCOVORIN, control r~urnber121931, received on May 7,2008, 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
Regulations, Division 5, in the sale of this product for clinical testing, In addition, the regulations
impose record keeping ~eqmnsibilitieson those conducting clinical trials.
You are aIso reminded that all clinical trials should be conducted in compliance with
the Therapeutic Products Dlirectorate's Guidelinefor Good Clinical Practice.
Should you have any questions concerning this letter, please contact the Office of
Clinical Trials (61 3) 941 -2132.
Yours sincerely,
-
C.Lourenco, Ph.D.
Manager - Clinical Tdals Group I
Office of Clinical Trials
TPD - OCT
1+1 Health
Canada
May 28 2008
14 :57
P. 01
$anti
Canada
Health Products add Food Branch
Direction giakrale dee produits de sanrk et des aliments
Therapeutic Products Diwectorate
Direction des produits thtrapeutiques
OUR MISSION: We contribute to the health of
Canadians and t o the effectiveness of the health care
systetn by regulating pharmaceuticals and medical
dcvices and by providing Canadians wirh access to
infonnatioe to makc informed choices.
NOTRE MISSION : Nous contrhuons l'adlioration de la swtB des
Canadiens et a 17efEicacit&du systeme de soins dc santk en
rkglementant lcs produits pharmaceutiqu~sct les materiels m i d i c a ~ ~otx
en offrant aux Canadied~un acces a l'infoimationpour qu'ils puissent
faire des chois iclairhg
If you receive this fax in error, please advise the sender immediately.
Si vous recevrlz cette t61Bcople par erreur, veuillez en awlser irnrnkdiatement I'exp6diteur.
- -..-
Erin J. CunainlJham
Y arnc/Pl[om;
Or~a~~izn~~ion/Orgnni;mc:
Tel..Tel.:
21 5-517483 1
oak;
--
-
Directmete
Building
Locatloll
Addrcns Locator
CityIPrcwince
21 5-574-0300
FsxTrt5lbcopicur:
2
No. of Pages, including:this pz,ge/NBc pagcs, incl~lantcctm page:
TITLE
Division
May 28,2008
A m r i m n Col lbge o:'Radiolofll Radiation n~llcrapyOncology Group
Mmrtscr -Clinical Trials Group I 1Gcalionnairc - P:opnimnc dcs cssais cliniqum Gmupc I
TITRE
Division
Direction
O f i c c of Clinical Trials / Burcau dcs caaais cliniquae
THERAPEUTIC PRODUCTS DIRECTORATEI
DIRECITON DES PRODUITS TH~RAPEUTIQUES
klolland Cross, Towcr B,Y" floor 15 iEmc dtagc Aolland Cww, Tour B
1600 Scott Street/ 1600 Ruc Scatt
3 105A
dificc
Licu
Localisetcur d'adrcssc
Vi\lt/Prbrincc
OTTAWA, Cmtario
PosLaI Codc
Code aostnl
,
KIA OK9
Websitelsite 'Web : http:/iwww,hc-sc,gc,~~dhp-mps/prodpharma/inde~XcCh~~
-
-
-
.--
-
MESSAGE
IMPORTANT:
Before submitting at1 application, plearre ensure that your C1) is In a CD Jewel Casejhard plastic CD case. The case is required
for etnring the CD appropriately. I Avant de sournettre votre demande, veuillez vous assourer que votre CD eet Inskr4 dans un
dtui rigide en plastique. L'dtui est n6qessaire afin de conserver le C;?)en bon &at.
r
11111
Clinical Trials ManuaIIManuel d'euais cliniq~es
--
Release off rotoeol SaZe_trand.EfficacyAssessment Temalate-Clinical Trial Annlication IFSEAT-CTA)!
Dlfllusion du Modble d'BvaluaiKon dc I'innocuitC et de l'efficadtb des urotocoles Demruuie d'essai cliniaua (MEIEP-DEC)
-
-