All
other forms not found on this page can be accessed by following
the links to the Food
and Drug Administration Forms Page
Commonly
used IND and BLA forms
Form
# |
Form |
Format
(s) |
Date
Form Expires |
| 1571 |
Investigational
New Drug Application (IND); Title 21, CFR Part 312 |
PDF
MS
Word |
May
31, 2009 |
| 1572 |
Statement
of Investigator (IND); Title 21, CFR Part 312 |
PDF |
May
31, 2009 |
| 356h |
Application
to Market a New Drug, Biologic, or an Antibiotic Drug
for Human Use;Title 21, CFR 314 & 601 |
PDF |
September
30, 2008 |
| 3674 |
Certification
of Compliance with Requirements of ClinicalTrials.gov
Data Bank |
PDF |
June
30, 2008 |
Other
FDA forms
| 2252 |
Transmittal
of Annual Reports for Drugs for Human Use
|
PDF |
May
31, 2008 |
| 2253 |
Transmittal
of Advertisements and Promotional Labeling for Drugs and
Biologics for Human Use
|
PDF |
May
31, 2008 |
| 2567 |
Transmittal
of Labels and Circulars
|
PDF |
September
30, 2008 |
| 2626 |
New
Drug Application/Biologic Licensing Application (Blue
Folder) Archival |
Not
Yet Electronic |
GPO
|
| 2626a |
New
Drug Application/Biologic Licensing Application (Red Folder)
Chemistry |
Not
Yet Electronic |
GPO
|
| 2626b |
New
Drug Application/Biologic Licensing Application (Yellow
Folder) Pharmacology |
Not
Yet Electronic |
GPO
|
| 2626c |
New
Drug Application/Biologic Licensing Application (Orange
Folder) Pharmacokinetic |
Not
Yet Electronic |
GPO
|
| 2626d |
New
Drug Application/Biologic Licensing Application (White
Folder) Microbiology |
Not
Yet Electronic |
GPO
|
| 2626e |
New
Drug Application/Biologic Licensing Application (Tan Folder)
Clinical Data |
Not
Yet Electronic |
GPO
|
| 2626f |
New
Drug Application/Biologic Licensing Application (Light
Green Folder) Statistics |
Not
Yet Electronic |
GPO
|
| 2626h |
New
Drug Application/Biologic Licensing Application (Maroon
Folder) Field Submission Chemistry |
Not
Yet Electronic |
GPO
|
| 2656 |
Registration
of Drug Establishment/Labeler Code Assignment - THIS FORM
MUST BE SUBMITTED IN TRIPLICATE
|
PDF |
December
31, 2007 |
| 2657 |
Drug Product Listing
(This form needs to be printed on legal (8 1/2 x 14) paper.)
|
PDF |
December
31, 2007 |
| 2830 |
Blood Establishment Registration and Product Listing
|
PDF |
March
31, 2009 |
| 3356 |
Establishment
Registration and Listing for Human Cells, Tissues, and
Cellular and Tissue-Based Products
|
PDF |
August
31, 2010 |
| 3397 |
Use
Fee Cover Sheet
|
HTML |
|
| 3454 |
Certification:
Financial Interest and Arrangements of Clinical Investigators
|
PDF |
April
30, 2009 |
| 3455 |
Disclosure:
Financial Interest and Arrangements of Clinical Investigators
|
PDF |
April
30, 2009 |
| 3486 |
Biological
Product Deviation Report Form (BPDR); Title 21, CFR
600 & 606
|
PDF, Word |
June
30, 2010 |
| 3500 |
MedWatch:
FDA Medical Product Reporting Program |
PDF |
October
31, 2008 |
| 3500a |
MedWatch: FDA Medical Products Reporting Program - Mandatory |
PDF |
October
31, 2008 |
| VAERS-1 |
Vaccine
Adverse Event Reporting System
|
PDF |
|
|