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About FDA
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FDA Forms
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| Form | Date | Food and Drug Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 0356h | 02/2012 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | (PDF - 559KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 04/2006 | {FDA has OMB approval to use the form until 8/31/2011}. Investigational New Drug Application | (PDF - 221KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 10/2005 | Investigational New Drug Application (IND) [Instructions] | (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 |
| 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 | 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 |
| 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 |
| 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 |
| 2675 | 08/1990 | Investigational New Drug Folder (Red) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2675a | 10/1986 | Investigational New Drug Folder (Green) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2675b | 10/1986 | Investigational New Drug Folder (Orange) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2914 | 05/2011 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary | (PDF - 747KB) |
RDRC 301-796-2050 |
| 2915 | 05/2011 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary | (PDF - 1.8MB) |
RDRC 301-796-2050 |
| 3316 | 08/1985 | DRUG MASTER FILE REVIEW BINDER-Red | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 3316a | 08/1985 | DRUG MASTER FILE ARCHIVAL BINDER-Blue | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 3331 | 10/2011 | NDA Field Alert Report | (PDF - 1.7MB) |
Surveillance Programs Team 301-796-3130 |
| 3397 | 01/2007 | User Fee Cover Sheet | (HTM - 0KB) |
Mike Jones 301-796-3602 |
| 3454 | 10/2009 | Certification: Financial Interest and Arrangements of Clinical Investigator | (PDF - 384KB) |
Leah W. Ripper 301-796-1282 |
| 3455 | 10/2009 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | (PDF - 400KB) |
Leah W. Ripper 301-796-1282 |
| 3500A | 06/2010 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions) | (HTM - 0KB) |
MedWatch 1-800-332-1088 |
| 3542 | 10/2010 | Patent Information Submitted Upon and After Approval of An NDA or Supplemen | (PDF - 412KB) |
Mary Ann Holovac, R.Ph. 240-276-8971 |
| 3542a | 10/2010 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supp | (PDF - 409KB) |
Mary Ann Holovac, R.Ph. 240-276-8971 |
| 3613b | 03/2010 | Supplementary Information Certificate of a Pharmaceutical Product | (PDF - 568KB) |
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 or CDRH 301-796-7400 or CVM 240-276-9212 |
| 3664 | 03/2011 | My Medicine Record | (PDF - 466KB) |
Cindi Fitzpatrick 301-796-3115 |
| 3671 | 11/2011 | Common EMEA/FDA Application for Orphan Medicinal Product Designation | (PDF - 569KB) |
Kathy Needleman 301-827-3666 |
| 3674 | 03/2012 | Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requireme | (PDF - 406KB) |
Jarilyn Dupont 301-796-4716 |
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