About FDA
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FDA Forms
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| Form | Date | Food and Drug Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 0356h | 01/2013 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Recommended for use with Adobe Acrobat 8 or 9) | (PDF - 1MB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 0356h | 01/2013 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Instructions Supplement) | (PDF - 107KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 01/2013 | Investigational New Drug Application (IND) [Instructions] | (PDF - 134KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 01/2013 | Investigational New Drug Application (IND) (Recommended for use with Adobe Acrobat 8 or 9) | (PDF - 771KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 02/2012 | Statement of Investigator Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) | (PDF - 1.1MB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 02/2012 | Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (Guidance) | (HTM - 0KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 05/2006 | (Use this if the newer version does not work for you) Statement of Investigator | (PDF - 219KB) |
CDER Drug Info 301-796-3400 |
| 2252 | 12/2011 | Transmittal of Annual Report for Drugs and Biologics for Human Use | (PDF - 662KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2253 | 09/2011 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | (PDF - 1.4MB) |
DDMAC 301-796-1200 |
| 2567 | 01/2011 | Transmittal of Labels and Circulars | (PDF - 424KB) | CBER MATT at 301-827-2000 |
| 2626 | 07/2004 | New Drug Application/Biologic Licensing Application (Blue Folder) Archival | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626a | 07/2004 | New Drug Application/Biologic Licensing Application (Red Folder) Chemistry | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626b | 07/2004 | New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626c | 07/2004 | New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626d | 07/2004 | New Drug Application/Biologic Licensing Application (White Folder) Microbiology | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626e | 07/2004 | New Drug Application/Biologic Licensing Application (Tan Folder) Clinical Data | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626f | 07/2004 | New Drug Application/Biologic Licensing Application (Light Green Folder) Statistics | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626h | 07/2004 | New Drug Application/Biologic Licensing Application (Maroon Folder) Field Submission Chemistry | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2830 | 03/2012 | Blood Establishment Registration and Product Listing | (PDF - 463KB) | bloodregis@fda.hhs.gov |
| 3356 | 11/2011 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | (PDF - 635KB) | tissuereg@fda.hhs.gov |
| 3356 | 01/2011 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (HTML) | (HTM - 0KB) | tissuereg@fda.hhs.gov |
| 3486 | 01/2011 | Biological Product Deviation Report (Instructions) | (HTM - 0KB) |
CBER PSB 301-827-6220 |
| 3486 | 10/2012 | Biological Product Deviation Report | (PDF - 483KB) |
CBER Program Surveillance Branch 301-827-6220 |
| 3486 | 01/2011 | Biological Product Deviation Report (HTML) | (HTM - 0KB) |
CBER Program Surveillance Branch 301-827-6220 |
| 3500A | 06/2010 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions) | (HTM - 0KB) |
MedWatch 1-800-332-1088 |
| 3613 | 03/2012 | Supplementary Information Certificate to Foreign Government Requests | (PDF - 506KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-9227. |
| 3613a | 03/2012 | Supplementary Information Certificate of Exportability Requests | (PDF - 527KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-9227. |
| 3613b | 03/2012 | Supplementary Information Certificate of a Pharmaceutical Product | (PDF - 585KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-9227. |
| 3613c | 03/2012 | Supplementary Information Non-Clinical Research Use Only Certificate | (PDF - 467KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 |
| VAERS-! | 02/2009 | Vaccine Adverse Event Reporting System | (PDF - 99KB) |
VAERS 800-822-7967 |
| VARES-1 | 02/2009 | Vaccine Adverse Event Reporting System (HTML) | (HTM - 0KB) |
VAERS 800-822-7967 |
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