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Ketek Hearing Exhibit Binder

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Exhibit Number	Description	Date
	Senate Finance Committee Reports
1	Senate Finance Committee report to FDA Commissioner von Eschenbach (with attachments).	12/13/2006
2	Senate Finance Committee report to FDA Commissioner von Eschenbach.	12/19/2007
	Cisneros Documents
3	Email from Christopher Jones, re: "Dr. Garner."	01/21/2002
4	Email from Jessica Lasley re: "Teleconference to discuss finding from monitoring Kirkman-Campbell."	02/27/2002
5	March 4, 2002 Meeting Minutes from Ranjan Khosla.	03/06/2002
	West Documents
6	Email from Robert West, re: "As I promised."	03/06/2003
7	Email from Robert West, re: "Dr. Campbell."	06/19/2003
8	Email from Robert West, re: "Per your request."	07/28/2003
	Ekey Documents
9	Case file memorandum, subject: Aventis Pharmaceuticals, Inc.- Ketek.
	Loveland Documents
10	FDA Office of Criminal Investigations (OCI) Report of Investigation (Loveland), subject: "Regulatory Background of NDA 21-144; Identifying Falsified Data in Study #3014 and Aventis' statements in defense of its submissions."	04/24/2007
11	FDA OCI Report of Investigation (Loveland), subject: "Subject and Witness Interviews Completed, Prosecution Denied."	07/30/2007
12	OCI Investigative Work Product, subject: "Ketek Fact Chronology."	05/02/2007
13	Letter to Douglas Loveland from Assistant U.S. Attorney Christopher Christie, re: "Investigation of Aventis Pharmaceuticals, Inc."	07/02/2007
14	Email from Kathy Martin-Weis, re: "Materiality and 1341."	07/10/2007
	Aventis Documents
15	Aventis Global Regulatory Standard Operating Procedure Scientific Misconduct and Fraud.	10/20/2000
16	Sanofi Aventis Scientific Misconduct- Serious GCP Non-Compliance policy.	06/01/2006
17	Aventis Pharma Clinical Study Protocol, Coordinating Investigatior: Paul Ianinni; subject: "HMR3647A/3014."	09/27/2001
18	Summary Table of GCP Issues, subject: "Telithromycin Respiratory Effectiveness Assessment Trial (TREAT) Protocol: HMR3647A/ 3014."
19	Aventis Clinical Study-Audit Report, Investigator: Anne Kirkman-Campbell.	02/05/2002
20	Email from Mary Tate, re: "site 1129."	03/06/2002
21	Email from Nadine Grethe, re: "Protocol Violation Tracker."	06/19/2002
22	Email from Anne Kirkman-Campbell, re: "FDA Visit."	10/16/2002
23	Email from Anne Kirkman-Campbell, re: "FDA Visit."	10/20/2002
24	Email from Michelle Snedeker (using Kirkman-Campbell's email) to Ranjan Khosla (no subject).	10/22/2002
25	Email from Kirkman-Campbell to Ranjan Khosla (no subject).	11/17/2002
26	Email from Ranjan Khosla, re: "Ketek Adult NDA 21-144: FDA Contact Report, October 24, 2002- FDA Form 483 for Kirkman-Campbell Site."	12/05/2002
27	Letter from Frances LeSane of FDA's Center for Drug Evaluation and Research to Helen Edelberg of Aventis Pharmaceuticals, subject: Meeting Minutes of December 19, 2002 Meeting.
28	Warning Letter to Aventis CEO Gregory Irace from Leslie Ball of FDA's Center for Drug Evaluation and Research.
29	Letter from Sanofi-Aventis to Leslie Ball re: "Warning Letter 07-HFD-45-1002."	11/19/2007
	PPD Documents
30	TREAT Trip Report Follow-up Form.	07/11/2002
31	Letter to Robert West from Robert McCormick of PPD Development, subject: "FDA Investigation of Dr. Anne Campbell for clinical study" (Regulatory Agency Communication Policy attached).	11/18/2002
	Copernicus Documents
32	Safety/Noncompliance Reporting Requirements, Procedure No. 108	02/01/2001
33	Telephone Contact Report, subject: "Anne Kirkman-Campbell, MD."	02/21/2002
	Additional Documents
34	David Ross presentation at Joint AIDAC/DSARMAC Meeting, subject: NDA 21-144 (Ketek) Data Integrity Issues.	12/15/2006
35	Agreement for Clinical Services between Aventis Pharmaceuticals and PPD Development, LLC.	11/01/2001