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U.S. Department of Health and Human Services

About FDA

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FDA Forms

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Form Date Food and Drug Administration Forms Format Contact Info
0356h  09/2014 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Instructions Supplement)  (PDF - 137KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
0356h  06/2014 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (PDF) (Recommended for use with Adobe Acrobat 8 or 9)  (PDF - 2.5MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571  07/2013 Investigational New Drug Application (IND) [Instructions]  (PDF - 124KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571  01/2013 Investigational New Drug Application (IND) (PDF) (Recommended for use with Adobe Acrobat 8 or 9)  (PDF - 830KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1572  07/2013 Statement of Investigator Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (PDF)  (PDF - 897KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1572  07/2013 Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (Guidance)  (PDF - 108KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2252  12/2013 Transmittal of Annual Report for Drugs and Biologics for Human Use (PDF)  (PDF - 771KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2253  04/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (Instructions Supplement)  (PDF - 190KB) DDMAC
301-796-1200
2253  01/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (PDF)  (PDF - 1.7MB) DDMAC
301-796-1200
2626  07/2004 New Drug Application/Biologic Licensing Application (Blue Folder) Archival  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626a  07/2004 New Drug Application/Biologic Licensing Application (Red Folder) Chemistry  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626b  07/2004 New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626c  07/2004 New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626d  07/2004 New Drug Application/Biologic Licensing Application (White Folder) Microbiology  (HTML - 14KB) CBER MATT at 240-402-8020
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 240-402-8020
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 240-402-8020
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 240-402-8020
CDER Drug Info at 301-796-3400
2830  03/2012 Blood Establishment Registration and Product Listing (PDF)  (PDF - 463KB) bloodregis@fda.hhs.gov
3356  05/2014 Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (PDF)  (PDF - 922KB) 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  11/2013 Biological Product Deviation Report (HTML)  (HTM - 0KB) CBER Program Surveillance Branch
240-402-9160
3486  05/2014 Biological Product Deviation Report (PDF)  (PDF - 767KB) CBER Program Surveillance Branch
240-402-9160
3486  05/2014 Biological Product Deviation Report (Instructions to HTML)  (HTM - 0KB) CBER PSB
240-402-9160
3486  01/2011 Biological Product Deviation Report (Instructions)  (HTM - 0KB) CBER Program Surveillance Branch
240-402-9160
3486a  11/2013 Biological Product Additional Information Deviation Report (HTML)  (HTM - 0KB) CBER Blood and Tissue Compliance Branch
301-827-6223
3486a  01/2013 Biological Product Addition Information Deviation Report (Instructions to HTML)  (HTM - 0KB) CBER Blood and Tissue Compliance Branch
301-827-6223
3500  02/2013 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF - 1.6MB) MEDWATCH
1-800-FDA-1088
3500A  02/2013 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)  (PDF - 1.3MB) MEDWATCH
1-800-FDA-1088
3500A  02/2013 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions)  (PDF - 217KB) MedWatch
1-800-332-1088
3500B  04/2013 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF - 1.2MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3613  03/2012 Supplementary Information Certificate to Foreign Government Requests (PDF)  (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)  (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)  (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)  (PDF - 467KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400
3674  02/2013 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requiremetsof ClinicalTrials.gov (PDF)  (PDF - 2.6MB) Patrick McNeilly
301- 796-2941
3674  02/2013 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) (Instructions/Supplemental)  (PDF - 129KB) Patrick McNeilly
301- 796-2941
3906  12/2013 Publication Request CFSAN (PDF)  (HTM - 0KB) CFSAN Publicaiotns
1-888-723-3366
VAERS-!  02/2009 Vaccine Adverse Event Reporting System (PDF)  (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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