No Objection Letter
Transcription
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: .- .... -. . -. FROMlDE Name,Worn: TKLE Pivis~on Directorate Buiiding Locarion AJdhss C, Loureneo, Ph.D. E.MaiVCourim tlcctmniquc - wlia [email protected];cr - 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 hike Licu Locelirateur d'adwrrsc VilldPr~yin~c Cedc poelal 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 h t t p : l / w w w . h c - s c . g c . c a / d h p - m p d p r o d p h aor~/index-f.html I m e of Protocol S a a ~ ~ s s e s s m e n t C l i n i c Trial a l Apulication CPSEAT-CTAII 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 or l/index-f.html