Fda Form 1571 Investigational New Drug Application printable pdf download

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Form Approved: OMB No. 0910-0014.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Expiration Date: May 31, 2009

FOOD AND DRUG ADMINISTRATION

See OMB Statement on Reverse.

NOTE: No drug may be shipped or clinical

INVESTIGATIONAL NEW DRUG APPLICATION (IND)

investigation

begun until an IND for that

(TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312)

investigation is in effect (21 CFR 312.40).

1. NAME OF SPONSOR

2. DATE OF SUBMISSION

3. ADDRESS (Number, Street, City, State and Zip Code)

4. TELEPHONE NUMBER

(Include Area Code)

5. NAME(S) OF DRUG (Include all available names: Trade, Generic, Chemical, Code)

6. IND NUMBER (If previously assigned)

7. INDICATION(S) (Covered by this submission)

8. PHASE(S) OF CLINICAL INVESTIGATION TO BE CONDUCTED:

PHASE 1

PHASE 2

PHASE 3

OTHER

(Specify)

9. LIST NUMBERS OF ALL INVESTIGATIONAL NEW

DRUG APPLICATIONS (21 CFR Part 312), NEW DRUG

OR ANTIBIOTIC APPLICATIONS

(21 CFR Part 314), DRUG MASTER FILES (21 CFR Part 314.420), AND PRODUCT LICENSE APPLICATIONS (21 CFR Part 601) REFERRED

TO IN THIS APPLICATION.

IND submission should be consecutively numbered. The initial IND should be numbered

10.

"Serial number: 0000." The next submission (e.g., amendment, report, or correspondence)

SERIAL NUMBER

should

numbered

"Serial

Number:

0001."

Subsequent

submissions

should

numbered consecutively in the order in which they are submitted.

11. THIS SUBMISSION CONTAINS THE FOLLOWING: (Check all that apply)

INITIAL INVESTIGATIONAL NEW DRUG APPLICATION (IND)

RESPONSE TO CLINICAL HOLD

PROTOCOL AMENDMENT(S):

INFORMATION AMENDMENT(S):

IND SAFETY REPORT(S):

NEW PROTOCOL

CHEMISTRY/MICROBIOLOGY

INITIAL WRITTEN REPORT

CHANGE IN PROTOCOL

PHARMACOLOGY/TOXICOLOGY

FOLLOW-UP TO A WRITTEN REPORT

NEW INVESTIGATOR

CLINICAL

RESPONSE TO FDA REQUEST FOR INFORMATION

ANNUAL REPORT

GENERAL CORRESPONDENCE

REQUEST FOR REINSTATEMENT OF IND THAT IS WITHDRAWN,

OTHER

(Specify)

INACTIVATED, TERMINATED OR DISCONTINUED

CHECK ONLY IF APPLICABLE

JUSTIFICATION STATEMENT MUST BE SUBMITTED WITH APPLICATION FOR ANY CHECKED BELOW. REFER TO THE CITED CFR

SECTION FOR FURTHER INFORMATION.

TREATMENT IND 21 CFR 312.35(b)

TREATMENT PROTOCOL 21 CFR 312.35(a)

CHARGE REQUEST/NOTIFICATION 21 CFR312.7(d)

FOR FDA USE ONLY

CDR/DBIND/DGD RECEIPT STAMP

DDR RECEIPT STAMP

DIVISION ASSIGNMENT:

IND NUMBER ASSIGNED:

FORM FDA 1571 (4/06)

PREVIOUS EDITION IS OBSOLETE.

PAGE 1 OF 2

PSC Media Arts (301) 443-1090

Fda Form 1571 Investigational New Drug Application

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