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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  03/2014 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Instructions Supplement)  (PDF - 168KB) CBER MATT at 301-827-2000
CDER Drug Info at 301-796-3400
0356h  01/2014 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 301-827-2000
CDER Drug Info at 301-796-3400
1571  07/2013 Investigational New Drug Application (IND) [Instructions]  (PDF - 124KB) CBER MATT at 301-827-2000
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 301-827-2000
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 301-827-2000
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 301-827-2000
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 301-827-2000
CDER Drug Info at 301-796-3400
2253  09/2013 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (Instructions Supplement)  (PDF - 143KB) 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 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)  (PDF - 747KB) RDRC
301-796-2050
2915  05/2011 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary (PDF)  (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  03/2013 NDA Field Alert Report (PDF)  (PDF - 2.7MB) Surveillance Programs Team
301-796-3130
3331a  05/2013 NDA Field Alert Report Automated (Instructions)  (HTM - 0KB) Surveillance Programs Team
301-796-3130
3331a  03/2013 NDA Field Alert Report Automated (PDF)  (PDF - 1.7MB) Surveillance Programs Team
301-796-3130
3397  01/2007 PDUFA User Fee Cover Sheet (HTML)  (HTM - 0KB) Ashley Jones or Beverly Friedman
301-796-7900
3454  04/2013 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF - 673KB) Colleen LoCicero
301-796-1114
3455  04/2013 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF - 674KB) Colleen LoCicero
301-796-1114
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 (Instructions)  (HTM - 0KB) MedWatch
1-800-332-1088
3500A  02/2013 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)  (PDF - 1.3MB) MEDWATCH
1-800-FDA-1088
3500B  04/2013 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF - 1.2MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3542  11/2013 Patent Information Submitted Upon and After Approval of An NDA or Supplement (PDF)  (PDF - 703KB) Kendra Stewart
240-276-8971
3542a  11/2013 Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement (PDF)  (PDF - 700KB) Kendra Stewart
240-276-8971
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.
3664  03/2011 My Medicine Record (PDF)  (PDF - 466KB) Cindi Fitzpatrick
301-796-3115
3671  11/2011 Common EMEA/FDA Application for Orphan Medicinal Product Designation (PDF)  (PDF - 569KB) Kathy Needleman
301-827-3666
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
3676  05/2013 Secure Supply Chain Pilot Program Application (PDF)  (PDF - 1.4MB) Katie Neckers
301-796-3339
3792  10/2012 Biosimilar User Fee Cover Sheet (HTML)  (HTM - 0KB) User Fee Financial Support
301-796-7200
3794  08/2013 Generic Drug User Fee Cover Sheet (Instructions)  (PDF - 650KB) User Fee Helpdesk
301-796-7200
3794  08/2013 Generic Drug User Fee Cover Sheet (HTML)  (HTM - 0KB) User Fee Helpdesk
301-796-7200
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