FDA Form # |
Date |
Title |
Format |
Paper Copy or Contact Info. |
356h |
10/05 |
Application to Market a New Drug,
Biologic or an Antibiotic Drug for Human Use |
|
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
1571 |
04/06 |
Investigational New Drug Application
{Instructions} |
|
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
1572 |
05/06 |
Statement of Investigator
{Instructions-CBER} |
|
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
2252 |
06/08 |
Transmittal of Annual Report for Drugs and Biologics
for Human Use |
|
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
2253 |
06/08 |
Transmittal of Advertisements and
Promotional Labeling for Drugs and Biologics for Human Use |
|
DDMAC 301-796-1200 |
2567 |
10/05 |
Transmittal of Labels and Circulars |
|
CBER MATT 301-827-2000 |
2656 |
04/06 |
Registration of Drug
Establishment/Labeler Code Assignment
{Instructions}
THIS FORM MUST BE SUBMITTED IN TRIPLICATE |
|
DRLS drls@fda.hhs.gov or 301-210-2840 |
2657 |
02/05 |
Drug Product Listing
{Instructions} |
|
DRLS drls@fda.hhs.gov or 301-210-2840 |
2830 |
07/06 |
Blood Establishment Registration and Product
Listing |
|
bloodregis@fda.hhs.gov |
3356 |
04/08 |
Establishment Registration and Listing
for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
|
tissuereg@fda.hhs.gov |
3397 |
1/03 |
User Fee Cover Sheet |
|
Mike Jones 301-443-5151 |
3454 |
04/06 |
Certification: Financial Interest and
Arrangements of Clinical Investigators |
|
Leah W. Ripper 301-796-1282 |
3455 |
04/06 |
Disclosure: Financial Interest and
Arrangements of Clinical Investigators |
|
Leah W. Ripper 301-796-1282 |
3486 |
08/07 |
Biological Product Deviation Report
{Instructions} |
|
CBER Program Surveillance Branch
301-827-6220 |
3500 |
02/06 |
MedWatch: The FDA Safety Information and Adverse Event Reporting Program {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
3500A |
02/06 |
MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
3613 |
09/06 |
Supplementary Information Certificate to Foreign Government Requests |
|
Import/Export Team CBER 301-827-6201 |
3613a |
09/06 |
Supplementary Information Certificate of Exportability Requests |
|
Import/Export Team CBER 301-827-6201 |
3613b |
06/06 |
Supplementary Information Certificate of a Pharmaceutical Product |
|
Import/Export Team CBER 301-827-6201 |
3613c |
09/06 |
Supplementary Information Non-Clinical Research Use Only Certificate |
|
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 |
VAERS-1 |
|
Vaccine Adverse Event Reporting System{Instructions} |
|
VAERS
800-822-7967 |