Dockets: 2006N-0464: Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

2006N-0464: Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

Document #	Received Date	Filed Date	Submitter Code	Submitter		FR Date				Remarks


NHC1		11/16/2006	FDA	FDA		11/21/2006	67356-67359	12/08/2006	txt
				Signature:	Janet Woodcock

EC1	11/28/2006	11/27/2006	Drug Industry	Genzyme Corporation					htm
				Signature:	Carle, Rachel

APE1	11/28/2006	11/27/2006	Private Industry	Piedmont Medical Group					pdf Attached CV
				Signature:	Doug Pierce

EC2	12/05/2006	12/01/2006	Device Industry	AGA Medical					htm
				Signature:	Rutkiewicz, Mark

EC3	12/06/2006	12/05/2006	International Industry	Newtech Global Solutions LLC					htm Attachment
				Signature:	Kaliannan, Ari

EC4	12/07/2006	12/06/2006	Drug Association	Pharm Res					pdf
				Signature:	Goldhammer, Alan

EC5	12/08/2006	12/07/2006	Private Industry	Virtify, Inc.					htm
				Signature:	Tadikonda, Satish

EC6	12/08/2006	12/07/2006	Drug Industry	TAP Pharmaceutical Products Inc					htm
				Signature:	Edwards, S. Albert

EC7	12/08/2006	12/07/2006	Private Industry	Datafarm Inc.					htm
				Signature:	McNiff, Sean

EC8	12/08/2006	12/07/2006	Health Professional	GlobalSubmit					htm
				Signature:	Rock, Jason

APE2	12/08/2006	12/08/2006	Private Industry	Alston & Bird LLP					pdf
				Signature:	Donald E. Segal

EC9	12/11/2006	12/08/2006	Drug Association	Biotechnology Industry Organization (BIO)					htm Attachment
				Signature:	Emmett, Andrew

EC10	12/11/2006	12/08/2006	International Organization	CDISC					htm Attachment
				Signature:	Mason, Tanyss

EC11	12/11/2006	12/08/2006	Other Organization	CRIX International, Association					htm Attachment
				Signature:	Tallent, Guy

EC12	12/11/2006	12/08/2006	Drug Industry	Mr. Robert Rainer					htm
				Signature:	Rainer, Robert

EC13	12/11/2006	12/08/2006	Private Industry	Octagon Research Solutions					htm
				Signature:	Smerkanich, nancy

EC14	12/11/2006	12/08/2006	Drug Industry	Genzyme Corporation					htm
				Signature:	Panagoulias, Jennifer

EC15	12/11/2006	12/08/2006	Private Industry	SAS					pdf
				Signature:	Lang, Sharon

EC16	12/11/2006	12/08/2006	Drug Industry	CommonPractice.org					pdf
				Signature:	Luce, David

EC17	12/11/2006	12/08/2006	Private Industry	ThinSpring					htm Attachment
				Signature:	Celeste, Ron

EC18	12/11/2006	12/08/2006	Drug Industry	Genentech, Inc.					pdf
				Signature:	van Gelder, Jan

EC19	12/11/2006	12/08/2006	Individual Consumer	MedWrite, Inc.					htm Attachment
				Signature:	Wood, Linda

EC20	12/11/2006	12/08/2006	Private Industry	Northrop Grumman Corporation					Table of Contents
				Signature:	Zagar, Terence

EC21	12/12/2006	12/11/2006	Drug Association	Pharm Res					pdf
				Signature:	Goldhammer, Alan

C1	12/11/2006	12/05/2006	Private Industry	Comprehensive Clinical Trials, LLC					pdf
				Signature:	Virginia Piechocniski

APE3	12/08/2006	12/08/2006	Private Industry	Alston & Bird, LLP					pdf
				Signature:	Donald E. Segal

EC22	12/14/2006	12/12/2006	Drug Industry	Dr. S. Albert Edwards					pdf
				Signature:	Edwards, S. Albert

EC23	12/14/2006	12/13/2006	Private Industry	Northrop Grumman Corporation					htm
				Signature:	Zagar, Terence

EMC1	12/06/2006	12/05/2006	Private Industry	NGS, Newtech Global Soluctions LLC					pdf
				Signature:	Ari Kaliannan

LST1	12/14/2006	12/14/2006	Federal Government	Panelists for the Part 15 Public Hearing					pdf
				Signature:	Panelists for the Part 15 Public Hearin

LST2	12/14/2006	12/14/2006	Federal Government	Part 15 Public Hearing Schedule					pdf
				Signature:	Part 15 Public Hearing Schedule

EC24	12/15/2006	12/14/2006	Drug Industry	Octagon Research Solutions					htm
				Signature:	Smerkanich, Nancy

EC25	12/18/2006	12/15/2006	Drug Industry	Hollister-Stier Laboratories LLC					pdf
				Signature:	Mirabell, David

EC26	12/18/2006	12/15/2006	Private Industry	SAS					htm
				Signature:	McFadden, Lee

EC27	12/18/2006	12/15/2006	Private Industry	Northrop Grumman Corporation					htm
				Signature:	Zagar, Terence

C2	12/18/2006	12/15/2006	Drug Industry	Ciba Specialty Chemicals Corporation (Ciba)					pdf
				Signature:	Michael Ruberto, PhD

TS1	12/15/2006	12/14/2006	Private Industry	Alston & Bird, LLP					pdf
				Signature:	Donald E. Segal

EMC2	12/20/2006	12/19/2006	Drug Industry	Isis Pharmaceuticals					pdf
				Signature:	Kim M. Johnson

EC28	12/26/2006	12/22/2006	Association	Cyber Security Industry Alliance					htm Att 1, Att 2
				Signature:	Kurtz, Paul

EMC3	12/29/2006	12/29/2006	Private Industry	St. Jude Children's Research Hospital					txt
				Signature:	Robert S. Lake, D. Mgt., M. A., R. A. C

EC29	01/19/2007	01/17/2007	Drug Industry	Dr. John Aitken					htm

EC30	01/19/2007	01/18/2007	Other Organization	CRIX International, Association					htm
				Signature:	Tallent, Guy

TR1	02/05/2007	02/05/2007	Federal Government	Transcript of the 12/18/06 Public Meeting					rtf

				Signature:	Transcript

TS2	02/05/2007	02/05/2007	Private Industry	TAP Pharmaceutical Products, Inc.					htm	The Desired (Required) State of Electronic Submissions
				Signature:	Dr. S. Albert Edwards


TS3	02/05/2007	02/05/2007	Private Industry	Clinical Ink TM					htm	Digital Source Documents
				Signature:	Clinical Ink TM

TS4	02/05/2007	02/05/2007	Private Industry	ThinSpring					htm	Electronic Submission of Regulatory Information
				Signature:	Ron Celeste


TS5	02/05/2007	02/05/2007	Private Industry	CDISC					htm	Clinical Data Interchange Standards Consortium
				Signature:	C. David Hardison, PhD and Wayne K


TS6	02/05/2007	02/05/2007	Private Industry	Surety, LLC					htm	Obstacles Faced by Going to an All-electronic Submission Environment
				Signature:	Tom Klaff


TS7	02/05/2007	02/05/2007	Private Industry	Octagon Research Solutions, Inc.					htm	Transition to and Implementation of Electronic Submissions
				Signature:	Nancy Smerkanich


TS8	02/05/2007	02/05/2007	Private Industry	Alston & Bird LLP					htm	Transition from Paper Submissions to Electronic Submissions

				Signature:	Marc J. Scheineson, Esq. and Donal E

TS9	02/05/2007	02/05/2007	Other Organization	Clinical Research Information Exchange CRIX					htm

				Signature:	Clinical Research Information Exchang
TS10	02/05/2007	02/05/2007	Private Industry	Pharmaceutical Research and Manufactureres of America (PhRMA)					htm	FDA Public Hearing on Electronic Submissions and Public-Private Partnerships


				Signature:	Ed Tripp, Abbot, and Bill Rosen, Pfize
TS11	02/05/2007	02/05/2007	Private Industry	JRRapoza Associates, Inc. and Newtech Global Solutions LLC					htm


				Signature:	John R. Rapoza, M.S., R.Ph. and Ari

TS12	02/05/2007	02/05/2007	Private Industry	AGA Medical Corporation					htm	Best Practices in Sharing Electronic Documentation in the Medical Device Industry
				Signature:	Mark Rutkiewicz


TS13	02/05/2007	02/05/2007	Private Industry	GlobalSubmit, Inc.					htm	Reducing the Cost of Electronic Submissions
				Signature:	Jason Rock


TS14	02/05/2007	02/05/2007	Private Industry	Northrop Grumman					htm	Defining the Future
				Signature:	Robert M. Cothren, PhD, Harry Fisher

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Page last updated: February 21, 2007