Appendix-C2 Cover-Letter Sign Up (What important informations should you put) PDF

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Example of filling. How to answer C2 Cover Letter and submit to FDA....

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Appendix C2 FDA-CRS Form 2.0

Cover Letter for Application

Clinical Trial Application for Pembrolizumab Plus Chemotherapy October 19, 2021 Rolando Enrique D. Domingo, MD Director General Food and Drug Administration 1781 Civic Drive, Filinvest City Alabang, Muntinlupa City Attention: Director Jesusa Joyce N. Cirunay Center for Drug Regulation and Research

Re: Clinical Trial Application/Import License Application/ Extension/Notification Full title of the trial: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTEB49) Investigational Product Name/Code: Pembrolizumab Plus, Protocol number: MK-3475B49 (CT Identifier No. NCT04895358) Clinical Trial Approval No: N/A (for approved CT) Dear Director Dear Madam/ Sir, As a member of the Contract Research Organization (CRO) of ABC Research Organization (Phils.), I would like to submit an application for the clinical trial to your good office regarding the Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of ChemotherapyCandidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49) with Protocol number: MK-3475-B49 (CT Identifier No. NCT04895358). This clinical trial is proposed to be conducted for 7 years. The safety and efficacy of Pembrolizumab plus a choice of chemotherapy will be compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor positive, human epidermal growth factor receptor 2Page 1 of 3

negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer, as per the summary of the said product. Merck Sharp & Dohme B.V. in the Netherlands manufactures Pembrolizumab Plus Chemotherapy, which is imported by Merck Sharp & Dohme (I.A.) LLC in the Philippines. If you have any queries, please call the undersigned person Ms. Rahana Ayessah M. Calib, cellphone number 09979020979. Thank you and we look forward to your immediate and positive response. Sincerely yours,

Rahana Ayessah M. Calib Contract Research Organization (CRO) of ABC Research Organization (Phils.) Pagadian City, Philippines 09979020979

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