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Agenda
Reg Review
ICR
ICR Documents
Supporting Statement A
Document
Date Uploaded
SUPPORTING STATEMENT FINAL 12-30-13.doc
12/30/2013
Supporting Statement B
Document
Date Uploaded
Supplementary Documents
Title
Document
Document Type
Date Uploaded
COMMENT BIOTECHNOLOGY IND APPENDIX A 8-26-13
COMMENT BIOTECHNOLOGY IND APPENDIX A 8-26-13.pdf
Supplementary Document
12/09/2013
COMMENT EVERYLIFE FOUND Attachment 1 8-26-13
COMMENT EVERYLIFE FOUND Attachment 1 8-26-13.pdf
Supplementary Document
12/09/2013
COMMENT HYMAN WITH Attachment 8-27-13
COMMENT HYMAN WITH Attachment 8-27-13.pdf
Supplementary Document
12/09/2013
COMMENT HYMAN ATTACHMENT 2 8-27-13
COMMENT HYMAN ATTACHMENT 2 8-27-13.pdf
Supplementary Document
12/09/2013
Public Comments
Author Name
Comment Document
Author Affiliation
Sponsoring Org.
Type
Category
Date of Comment
Date Comment Received
Slone, Kelly
COMMENT NVCA AND MedIC 8-26-13.pdf
Nat'l Venture Capital Associations Medical Innovation and Competitiveness Coalition
Letter
Simple
08/26/2013
08/29/2013
Koerner, Chin
COMMENT NOVARTIS 8-21-13.pdf
Novartis
Letter
Simple
08/21/2013
08/29/2013
Robertson, Andrew
COMMENT MERCK CO INC 8-23-13.pdf
Merck & Co., Inc.
Letter
Simple
08/23/2013
08/29/2013
Berg, Nancy S.
COMMENT INTERNATIONAL SOCIETY FOR PEs 8-23-13.doc
International Society for PE
Letter
Simple
08/23/2013
08/29/2013
, Anonymous
COMMENT ANONYMOUS 8-5-2013.txt
Other -- Web
Simple
08/05/2013
08/05/2013
Bronstein, Ned
COMMENT REGENERON 8-23-13.doc
Regeneron Pharmaceuticals Inc.
Letter
Simple
08/23/2013
08/29/2013
Vereshchagina, Lucy
COMMENT PhRMA 8-26-13.pdf
PhRMA
Letter
Simple
08/26/2013
08/26/2013
Hudis, MD., Clifford A.
COMMENT AMERICAN SOC OF CLINICAL ONCOLOGY 8-26-13.pdf
ASCO
Letter
Simple
08/25/2013
09/05/2013
Noah, Lara
COMMENT AKESIS 8-5-13.txt
Akesis
Other -- WEB
Simple
08/05/2013
08/08/2013
Gonzalez, Sylvia
COMMENT GONZELEZ 8-24-13.pdf
Letter
Simple
08/24/2013
08/24/2013
, Cosigned by 33 Organizations
COMMENT EVERYLIFE FOUND LTR 8-26-13.pdf
Everylife Foundation
Letter
Simple
08/26/2013
09/05/2013
, Cancer Leadership Council
COMMENT CANCER LEADERSHIP 8-26-13.pdf
Letter
Simple
08/26/2013
08/29/2013
Morsy, Manal
COMMENT ATHERSYS 8-16-13.pdf
Athersys, Inc.
Letter
Simple
08/16/2013
08/16/2013
Haley, Carol
COMMENT PFIZER 8-26-13.pdf
Pfizer Inc.
Letter
Simple
08/26/2013
08/29/2013
Clark, Robert B.
COMMENT NOVO NORDISK 8-22-13.pdf
Novo Nordisk
Letter
Simple
08/22/2013
09/05/2013
Saltonstall, Peter
COMMENT NATIONAL ORG FOR RARE DIS 8-26-13.pdf
National Organization for Rare Disorders
Letter
Simple
08/26/2013
08/29/2013
Velleca, M.D., Mark
COMMENT LEUKEMIA and LYMPHOMA SOC 8-26-13.pdf
The Leukemia and Lymphoma Society
Letter
Simple
08/26/2013
08/29/2013
Bronstein, Kathy
COMMENT SUDLER AND HENNESSEY 8-8-13.txt
Sudler & Hennessey
Other -- WEB
Simple
07/22/2013
08/08/2013
Furlong, Pat
COMMENT PPMD 8-22-13.pdf
Parent Project Muscular Dystrophy
Letter
Simple
08/22/2013
08/29/2013
, Anonymous
COMMENT ANONYMOUS 2 8-15-13.txt
Other -- WEB
Simple
08/15/2013
09/30/2013
Werner, Michael
COMMENT ALLIANCE 8-26-13.pdf
Alliance
Letter
Simple
08/26/2013
08/29/2013
Thomasell, James
COMMENT ACRP 8-16-13.pdf
ACRP
Letter
Simple
08/16/2013
08/16/2013
Sasinowski, Frank J.
COMMENT HYMAN 8-5-13.pdf
Hyman, Phelps, McNamara
Letter
Simple
08/27/2013
08/27/2013
Rohrer, Michelle H.
COMMENT GENENTECH 8-26-13.pdf
Genentech
Letter
Simple
08/26/2013
08/29/2013
Beall, Robert
COMMENT CYSTIC FIBROSIS 8-26-13.pdf
CFF
Letter
Simple
08/26/2013
08/29/2013
Emmett, Andrew
COMMENT BIOTECHNOLOGY IND 8-26-13.pdf
Biotechnology Industry Org.
Letter
Simple
08/26/2013
08/29/2013
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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