Fda 1571 - Investigational New Drug Application (Ind)
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Form Approved: OMB No. 0910-0014
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Expiration Date: February 28, 2019
Food and Drug Administration
See PRA Statement on page 3.
INVESTIGATIONAL NEW DRUG APPLICATION (IND)
NOTE: No drug/biologic may be shipped or
clinical 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 (mm/dd/yyyy)
3. Sponsor Address
4. Telephone Number (Include country code if
applicable and area code)
Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
State/Province/Region
Country
ZIP or Postal Code
5. Name(s) of Drug (Include all available names: Trade, Generic, Chemical, or Code)
6. IND Number (If previously assigned)
Continuation
Page for #5
7. (Proposed) Indication for Use
Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Yes
No
Does this product have an FDA
If yes, provide the Orphan
Orphan Designation for this
Designation number for this
Continuation
indication?
indication:
Page for #7
Yes
No
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 Applications (21 CFR Part 314) , Drug Master Files (21
CFR Part 314.420) , and Biologics License Applications (21 CFR Part 601) referred to in this application.
10. IND submission should be consecutively numbered. The initial IND should be numbered “Serial number: 0000.”
Serial Number
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.
11. This submission contains the following (Select all that apply)
Initial Investigational New Drug Application (IND)
Response to Clinical Hold
Response To FDA Request For Information
Request For Reactivation Or Reinstatement
Annual Report
General Correspondence
Development Safety Update Report (DSUR)
Other (Specify):
Protocol Amendment(s)
Information Amendment(s)
Request for
IND Safety Report(s)
New Protocol
Chemistry/Microbiology
Meeting
Initial Written Report
Change in Protocol
Pharmacology/Toxicology
Proprietary Name Review
Follow-up to a Written
Report
New Investigator
Clinical
Statistics
Special Protocol Assessment
PMR/PMC Protocol
Clinical Pharmacology
Formal Dispute Resolution
12. Select the following only if applicable. (Justification statement must be submitted with application for any items selected below. Refer
to the cited CFR section for further information.)
Expanded Access Use, 21 CFR 312.300
Emergency Research Exception From Informed Consent
Individual Patient, Non-
Intermediate Size Patient
Requirements, 21 CFR 312.23 (f)
Emergency 21 CFR 312.310
Population, 21 CFR 312.315
Charge Request, 21 CFR 312.8
Individual Patient, Emergency
Treatment IND or Protocol,
21 CFR 312.310(d)
21 CFR 312.320
For FDA Use Only
CBER/DCC Receipt Stamp
DDR Receipt Stamp
Division Assignment
IND Number Assigned
FORM FDA 1571 (2/16)
Page 1 of
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PSC Publishing Services (301) 443-6740
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