Fillable Fda 1571 - Investigational New Drug Application (Ind) (Page 2 of 3) in pdf

13. Contents of Application – This application contains the following items (Select all that apply)

6. Protocol(s) (Continued)

1. Form FDA 1571 (21 CFR 312.23(a)(1))

d. Institutional Review Board data (21 CFR 312.23(a)(6)(iii)

2. Table of Contents (21 CFR 312.23(a)(2))

(b)) or completed Form(s) FDA 1572

3. Introductory statement (21 CFR 312.23(a)(3))

7. Chemistry, manufacturing, and control data

4. General Investigational plan (21 CFR 312.23(a)(3))

(21 CFR 312.23(a)(7))

5. Investigator’s brochure (21 CFR 312.23(a)(5))

Environmental assessment or claim for exclusion

(21 CFR 312.23(a)(7)(iv)(e))

6. Protocol(s) (21 CFR 312.23(a)(6))

8. Pharmacology and toxicology data (21 CFR 312.23(a)(8))

a. Study protocol(s) (21 CFR 312.23(a)(6))

9. Previous human experience (21 CFR 312.23(a)(9))

b. Investigator data (21 CFR 312.23(a)(6)(iii)(b)) or

10. Additional information (21 CFR 312.23(a)(10))

completed Form(s) FDA 1572

11. Biosimilar User Fee Cover Sheet (Form FDA 3792)

c. Facilities data (21 CFR 312.23(a)(6)(iii)(b)) or completed

12. Clinical Trials Certification of Compliance (Form FDA 3674)

Form(s) FDA 1572

14. Is any part of the clinical study to be conducted by a contract research organization?

Yes

If Yes, will any sponsor obligations be transferred to the contract research organization?

Yes

Continuation

If Yes, provide a statement containing the name and address of the contract research organization,

Page for #14

identification of the clinical study, and a listing of the obligations transferred (use continuation page).

15. Name and Title of the person responsible for monitoring the conduct and progress of the clinical investigations

16. Name(s) and Title(s) of the person(s) responsible for review and evaluation of information relevant to the safety of the drug

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 covered by the IND if those

studies are placed on clinical hold or financial hold. I agree that an Institutional Review Board (IRB) that complies with the

requirements set forth in 21 CFR Part 56 will be responsible for initial and continuing review and approval of each of the

studies in the proposed clinical investigation. I agree to conduct the investigation in accordance with all other applicable

regulatory requirements.

17. Name of Sponsor or Sponsor’s Authorized Representative

(Include country code if applicable and area code)

18. Telephone Number

19. Facsimile (FAX) Number

20. Address

21. Email Address

Address 1 (Street address, P.O. box, company name c/o)

Address 2 (Apartment, suite, unit, building, floor, etc.)

22. Date of Sponsor’s Signature (mm/dd/yyyy)

City

State/Province/Region

Country

ZIP or Postal Code

23. Name of Countersigner

24. Address of Countersigner

Address 1 (Street address, P.O. box, company name c/o)

Address 2 (Apartment, suite, unit, building, floor, etc.)

City

State/Province/Region

WARNING : A willfully false statement

is a criminal offense (U.S.C. Title 18,

Country

ZIP or Postal Code

Sec. 1001).

United States of America

25. Signature of Sponsor or Sponsor’s Authorized Representative

26. Signature of Countersigner

Sign

FORM FDA 1571 (2/16)

Page 2 of

Fda 1571 - Investigational New Drug Application (Ind) Page 2

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