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FDA Forms Distribution Page for Center for Biologics Evaluation Research (CBER)
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| FDA Form # | Date | Title | Format | Paper Copy or Contact Info. |
|---|---|---|---|---|
| 356h | 04/03 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | |
Pamela Pope 301-827-9540 |
| 1571 | 01/03 | Investigational New Drug Application {Instructions} | |
Mia Prather Mia.Prather@fda.hhs.gov |
| 1572 | 01/03 | Statement of Investigator {Instructions} | |
Mia Prather Mia.Prather@fda.hhs.gov |
| 2252 | 04/02 | Transmittal of Annual Report for Drugs for Human Use | |
Mia Prather Mia.Prather@fda.hhs.gov |
| 2253 | 07/02 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | |
Mike Wade 301-827-2828 |
| 2567 | 09/02 | Transmittal of Labels and Circulars | |
Pamela Pope 301-827-9540 |
| 2626 | 07/04 | New Drug Application/Biologic Licensing Application (Blue Folder) Archival | Not Yet Electronic | GPO |
| 2626a | 07/04 | New Drug Application/Biologic Licensing Application (Red Folder) Chemistry | Not Yet Electronic | GPO |
| 2626b | 07/04 | New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology | Not Yet Electronic | GPO |
| 2626c | 07/04 | New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic | Not Yet Electronic | GPO |
| 2626d | 07/04 | New Drug Application/Biologic Licensing Application (White Folder) Microbiology | Not Yet Electronic | GPO |
| 2626e | 07/04 | New Drug Application/Biologic Licensing Application (Tan Folder) Clinical Data | Not Yet Electronic | GPO |
| 2626f | 07/04 | New Drug Application/Biologic Licensing Application (Light Green Folder) Statistics | Not Yet Electronic | GPO |
| 2626h | 07/04 | New Drug Application/Biologic Licensing Application (Maroon Folder) Field Submission Chemistry | Not Yet Electronic | GPO |
| 2830 | 02/03 | Blood Establishment Registration and Product Listing {Instructions} | |
Janet Ishimoto 301-827-3543 |
| 3356 | 08/04 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products | |
tissuereg@cber.fda.gov |
| 3397 | 12/03 | User Fee Cover Sheet | |
Mike Jones 301-594-2041 |
| 3454 | 02/03 | Certification: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-827-5921 |
| 3455 | 02/03 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-827-5921 |
| 3486 | 07/04 | Biological Product Deviation Report {Instructions} | |
Sharon O'Callaghan
301-827-6220 |
| 3500 | 09/03 | MedWatch: FDA Medical Product Reporting Program {Instructions} | |
MEDWATCH 1-800-FDA-1088 |
| 3500A | 09/03 | MedWatch: FDA Medical Products Reporting Program - Mandatory {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| VAERS-1 | |
Vaccine Adverse Event Reporting System | |
VAERS 800-822-7967 |
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Edition: September 30, 2004