(21 CFR Part 601) REFERRED TO IN
THIS APPLICATION.
72,862
72,990
74,532
10.
IND submission should be consecutively numbered. The initial IND should be
numbered "Serial number: 0000." The next submission (e.g., amendment, report, or
correspondence) should be numbered "Serial Number: 0001." Subsequent submissions
should be numbered consecutively in the order in which they are submitted.
SERIAL NUMBER
0
1
2
0
11.
THIS SUBMISSION CONTAINS THE FOLLOWING: (Check all that apply)
o INITIAL INVESTIGATIONAL NEW DRUG APPLICATION (IND)
o RESPONSE
TO CLINICAL HOLD
PROTOCOL AMENDMENT(S):
INFORMATION AMENDMENT(S):
IND SAFETY REPORT(S):
o
NEW PROTOCOL
o CHEMISTRY/MICROBIOLOGY
o INITIAL WRITTEN REPORT
o
CHANGE IN PROTOCOL
o PHARMACOLOGY/TOXICOLOGY
o FOLLOW-UP TO A WRITTEN REPORT
o
NEW INVESTIGATOR
o CLINICAL
o
RESPONSE TO FDA REQUEST FOR INFORMATION
o ANNUAL REPORT
x GENERAL CORRESPONDENCE
o
REQUEST FOR REINSTATEMENT OF IND THAT IS WITHDRAWN,
x OTHER
Change in ownership
INACTIVATED, TERMINATED OR DISCONTINUED
(Specify)
CHECK ONLY IF APPLICABLE
JUSTIFICATION STATEMENT MUST BE SUBMITTED WITH APPLICATION FOR ANY CHECKED
BELOW. REFER TO THE CITED CFR SECTION FOR FURTHER INFORMATION.
o TREATMENT IND 21 CFR 312.35(b)
o TREATMENT PROTOCOL 21 CFR 312.35(a)
o CHARGE REQUEST/NOTIFICATION 21 CFR312.7(d)
FOR FDA USE ONLY
CDR/DBIND/DGD RECEIPT STAMP
DDR RECEIPT STAMP
DIVISION ASSIGNMENT:
IND NUMBER ASSIGNED:
12.
CONTENTS OF APPLICATION
This application contains the following items: (Check all that apply)
x
1. Form FDA 1571 [21 CFR 312.23(a)(1)]
o
2. Table of Contents [21 CFR 312.23(a)(2)]
o
3. Introductory statement [21 CFR 312.23(a)(3)]
o
4. General Investigational plan [21 CFR 312.23(a)(3)]
o
5. Investigator's brochure [21 CFR 312.23(a)(5)]
o
6. Protocol(s) [21 CFR 312.23(a)(6)]
o
a. Study protocol(s) [21 CFR 312.23(a)(6)]
o
b. Investigator data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572
o
c. Facilities data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572
o
d. Institutional Review Board data [21 CFR 312.23(a)(6)(iii)(b)] or completed
Form(s) FDA 1572
o
7. Chemistry, manufacturing, and control data [21 CFR 312.23(a)(7)]
o
Environmental assessment or claim for exclusion [21 CFR 312.23(a)(7)(iv)(e)]
o
8. Pharmacology and toxicology data [21 CFR 312.23(a)(8)]
o
9. Previous human experience [21 CFR 312.23(a)(9)]
o
10. Additional information [21 CFR 312.23(a)(10)]
13.
IS ANY PART OF THE CLINICAL STUDY TO BE CONDUCTED BY A CONTRACT RESEARCH
ORGANIZATION?
x YES
o NO
IF YES, WILL ANY SPONSOR OBLIGATIONS BE TRANSFERRED TO THE CONTRACT RESEARCH
ORGANIZATION?
x YES
o NO
IF YES, ATTACH A STATEMENT CONTAINING THE NAME AND ADDRESS OF THE CONTRACT
RESEARCH ORGANIZATION, IDENTIFICATION OF THE CLINICAL STUDY, AND A LISTING OF
THE OBLIGATIONS TRANSFERRED.
14.
NAME AND TITLE OF THE PERSON RESPONSIBLE FOR MONITORING THE CONDUCT AND PROGRESS
OF THE CLINICAL INVESTIGATIONS
TopoTarget Responsible Person
15.
NAME(S) AND TITLE(S) OF THE PERSON(S) RESPONSIBLE FOR REVIEW AND EVALUATION OF
INFORMATION RELEVANT TO THE SAFETY OF THE DRUG
TopoTarget Responsible Person
I agree not to begin clinical investigations until 30 days after FDA's receipt
of the IND unless I receive earlier notification by FDA that the studies may
begin. I also agree not to begin or continue clinical investigations