|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
| CP1
|
| 02/19/2003
|
| 02/19/2003
|
| Private Industry
|
| Aventis Pharmaceuticals
Inc.
|
|
|
|
|
|
|
| pdf
References
|
| ACK 2/19/03
|
|
|
| Signature:
|
| Larry Bell, M.D. & Peter
O. Safir
|
|
|
|
|
| ACK1
|
| 02/19/2003
|
| 02/19/2003
|
| Other Organization
|
| HFA-305
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Lyle D. Jaffe
|
|
|
|
|
| LET1
|
| 08/06/2003
|
| 08/06/2003
|
| Federal Government
|
| HFD-5 to Covington&
Burling
|
|
|
|
|
|
|
| pdf
|
| INT. 8/5/2003 SEE
CP1`
|
|
|
|
|
| Signature:
|
| Jane A. Axelrad
|
|
|
|
|
|
|
| C1
|
| 10/17/2003
|
| 10/17/2003
|
| Private Industry
|
| Hyman, Phelps &
McNamara, PC
|
|
|
|
|
|
|
| pdf
|
| Comment in opposition
to CP1 found in this docket.
|
|
|
| Signature:
|
| Robert A. Dormer & Anne
Marie Murph
|
|
|
|
|
|
|
|
|
|
|
| SUP1
|
| 02/12/2004
|
| 02/12/2004
|
| Drug Industry
|
| Aventis Pharmaceuticals,
Inc. (Aventis)
|
|
|
|
|
|
|
| Table
of Contents
|
|
|
|
|
| Signature:
|
| Larry Bell, MD & Peter O.
Safir
|
|
|
|
|
|
| C2
|
| 06/03/2004
|
| 06/03/2004
|
| Drug Industry
|
| Amphastar Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| pdf
|
| Answered June 1, 2004.
|
|
|
|
|
| Signature:
|
| Stephen A. Campbell, Esq
|
|
|
|
|
| C3
|
| 08/08/2004
|
| 08/08/2004
|
| Private Industry
|
| Hyman, Phelps &
McNamara, PC
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Robert A. Dormer and Anne Marie
Mu
|
|
|
|
|
| C4
|
| 08/26/2004
|
| 08/25/2004
|
| Drug Industry
|
| Teva Pharmaceuticals,
USA
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Deborah A. Jaskot
|
|
|
|
|
| C5
|
| 09/01/2004
|
| 09/01/2004
|
| Drug Industry
|
| Aventis
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Larry Bell, MD
|
|
|
|
|
| EMC1
|
| 08/25/2004
|
| 08/25/2004
|
| Drug Industry
|
| Teva Pharmaceuticals
USA, Inc. (TEVA)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Deborah A. Jaskot
|
|
|
|
|
| RC1
|
| 10/14/2004
|
| 10/14/2004
|
| Drug Industry
|
| Aventis Pharmaceuticals
Inc.
|
|
|
|
|
|
|
| pdf
References
|
|
|
|
|
| Signature:
|
| Peter O. Safir
|
|
|
|
|
| C6
|
| 11/24/2004
|
| 11/23/2004
|
| Drug Industry
|
| Amphastar Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Stephen A. Campbell, Esq
|
|
|
|
|
| RC2
|
| 03/17/2005
|
| 03/17/2005
|
| Drug Industry
|
| Aventis Pharmaceuticals
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Peter O. Safir
|
|
|
|
|
|
| C7
|
| 07/19/2005
|
| 07/18/2005
|
| Drug Industry
|
| Amphastar Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Stephen A. Campbell, Esq
|
|
|
|
|
| SUP2
|
| 09/26/2005
|
| 09/26/2005
|
| Drug Industry
|
| Aventis Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| Table
of Contents
|
|
|
|
|
| Signature:
|
| Steve Caffe, M.D., Peter O.
Safir, Sco
|
|
|
|
|
| C8
|
| 10/06/2005
|
| 10/06/2005
|
| Drug Industry
|
| Amphastar Pharmaceuticals
Inc
|
|
|
|
|
|
|
| Table
of Contents
|
|
|
|
|
| Signature:
|
| Stephen A Campbell Esq
|
|
|
|
|
| CR1
|
| 10/07/2005
|
| 10/07/2005
|
| Drug Industry
|
| Amphastar Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| Table
of Contents
|
| See C 8
|
|
|
| Signature:
|
| Stephen A. Campbell, Esq.
|
|
|
|
|
| C9
|
| 03/17/2006
|
| 03/16/2006
|
| Drug Industry
|
| sanofi-aventis US
LLC
|
|
|
|
|
|
|
| Comment
Attachment
|
|
|
|
|
| Signature:
|
| Peter O. Safir
|
|
|
|
|
| C10
|
| 04/18/2006
|
| 04/12/2006
|
| Individual Consumer
|
| D. Lowe
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| David Lowe
| |
|
|
|
| C11
|
| 08/25/2006
|
| 08/25/2006
|
| Drug Industry
|
| sanofi-aventis US
LLC
|
|
|
|
|
|
|
| pdf
Attachment
|
|
|
|
|
| Signature:
|
| Scott L. Cunningham
|
|
|
|
|
| SUP3
|
| 09/14/2006
|
| 09/14/2006
|
| Drug Industry
|
| Sanofi-aventis US
LLC
|
|
|
|
|
|
|
| Table
of Contents
|
|
|
|
|
| Signature:
|
| Mark Moyer & Peter O. Safir
| |
|
|
|
| C12
|
| 03/06/2007
|
| 03/06/2007
|
| Academia
|
| Massachussetts Institute
of Technology
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Robert S. Langer
|
|
|
|
|
| C13
|
| 03/06/2007
|
| 03/06/2007
|
| Academia
|
| Massachussetts Institute of Technology-Center for Biomedical Engineering
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Ram Sasisekharan, Ph. D.
|
|
|
|
|
| SUP4
|
| 03/05/2007
|
| 03/02/2007
|
| Private Industry
|
| Sanofi-aventis U.S.
LLC
|
|
|
|
|
|
|
| pdf
Appendix
|
|
|
|
|
| Signature:
|
| Peter O Safir
|
|
|
|
|
| RC3
|
| 03/19/2007
|
| 03/19/2007
|
| Private Industry
|
| Sanofi Aventis
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Douglas Greene MD
| |
|
|
|
| EMC2
|
| 03/28/2007
|
| 03/28/2007
|
| Academia
|
| Campbell University
School of Pharmacy
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| James B. Groce, PharmD, CACP
|
|
|
|
|
| SUP5
|
| 06/29/2007
|
| 06/29/2007
|
| Private Industry
|
| Sanofi-aventis, U.
S., L. L. C.
|
|
|
|
|
|
|
| Table
of Contents
|
|
|
|
|
| Signature:
|
| Richard P. Gural, Ph. D.
| |
|
|
