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About FDA
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FDA Forms
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| Form | Date | Food and Drugs Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 0356h | 10/2005 | {FDA has OMB approval to use the form until 6/30/2010} Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | (PDF - 264KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 04/2006 | Investigational New Drug Application | (PDF - 221KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 05/2006 | Statement of Investigator (CDER/CBER) | (PDF - 208KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2252 | 06/2008 | Transmittal of Annual Report for Drugs and Biologics for Human Use | (PDF - 339KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2253 | 06/2008 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | (PDF - 351KB) |
DDMAC 301-796-1200 |
| 2567 | 10/2005 | Transmittal of Labels and Circulars | (PDF - 161KB) | 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 |
| 2656 | 06/2009 | Registration Of Drug Establishment/Labeler Code Assignment (HTML) | (HTM - 0KB) | eDRLS@fda.hhs.gov |
| 2830 | 07/2006 | Blood Establishment Registration and Product Listing | (PDF - 312KB) | bloodregis@fda.hhs.gov |
| 3356 | 04/2008 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | (PDF - 647KB) | tissuereg@fda.hhs.gov |
| 3356 | 04/2008 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (HTML) | (HTM - 0KB) | tissuereg@fda.hhs.gov |
| 3486 | 04/2008 | Biological Product Deviation Report (HTML) | (HTM - 0KB) |
CBER Program Surveillance Branch 301-827-6220 |
| 3486 | 04/2008 | Biological Product Deviation Report | (PDF - 412KB) |
CBER Program Surveillance Branch 301-827-6220 |
| 3613 | 06/2006 | Supplementary Information Certificate to Foreign Government Requests | (PDF - 201KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613a | 09/2006 | Supplementary Information Certificate of Exportability Requests | (PDF - 403KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613b | 06/2006 | Supplementary Information Certificate of a Pharmaceutical Product | (PDF - 328KB) |
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613c | 06/2006 | Supplementary Information Non-Clinical Research Use Only Certificate | (PDF - 311KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 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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