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Form Date Description Format Contact Info
0356h  08/2018 Application to Market a New or Abbreviated New Drug or Biologic for Human Use (Instructions Supplement)  (PDF - 185KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
0356h  08/2018 Application to Market a New or Abbreviated New Drug or Biologic for Human Use (PDF)  (PDF - 2.4MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571  07/2018 Investigational New Drug Application (IND) [Instructions]  (PDF - 179KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571  07/2018 Investigational New Drug Application (IND) (PDF)  (PDF - 1.8MB) 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
1572  02/2016 Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312)(PDF) At this time, the attached PDF document may not be fully accessible to readers using assistive technology. In the event you are unable to read and/or complete portions of the form, please contact CDER's Division of Drug Information at 301-796-3400 or druginfo@fda.hhs.gov  (PDF - 1.1MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2252  11/2014 Transmittal of Annual Report for Drugs and Biologics for Human Use (Instructions Supplement) (PDF)  (PDF - 116KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2252  03/2018 Transmittal of Annual Report for Drugs and Biologics for Human Use (PDF)  (PDF - 853KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2253  03/2018 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (PDF)  (PDF - 1.7MB) DDMAC
301-796-1200
2253  04/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (Instructions Supplement)  (PDF - 190KB) 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
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  10/2018 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary (PDF)  (PDF - 804KB) RDRC
301-796-2050
2915  01/2018 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary (PDF)  (PDF - 1.9MB) 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
3331a  03/2018 NDA/ANDA Field Alert Automated(PDF)  (PDF - 2.6MB) Surveillance Programs Team
301-796-3130
3331a  05/2017 NDA/ANDA Field Alert Report Automated (Instructions)  (PDF - 143KB) Surveillance Programs Team
301-796-3130
3397  03/2016 PDUFA User Fee Cover Sheet (HTML)  (HTM - 0KB) CDER Collections at 301.796.7900
3454  03/2016 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF - 673KB) Liz Chen
240-402-3729
3455  03/2016 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF - 673KB) Liz Chen
240-402-3729
3500  10/2015 MedWatch: Information and Adverse Event Reporting Program - Voluntary (HTML)  (HTM - 0KB) CDER Drug Info:
(888) 463-6332
3500  10/2015 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF - 2.4MB) MEDWATCH
1-800-FDA-1088
3500A  10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (HTML)  (HTM - 0KB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3500A  10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)  (PDF - 2.5MB) MEDWATCH
1-800-FDA-1088
3500A  04/2016 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions)  (PDF - 250KB) MedWatch
1-800-332-1088
3500B  09/2018 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF - 1.3MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3542  11/2016 Patent Information Submitted Upon and After Approval of An NDA or Supplement-CDER (Instructions)  (PDF - 137KB) Kendra Stewart
240-402-8797
3542  08/2016 Patent Information Submitted Upon and After Approval of An NDA or Supplement (PDF)  (PDF - 3MB) Kendra S. Stewart
240-402-8797
3542a  08/2016 Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement (PDF)  (PDF - 3MB) Kendra S. Stewart
240-402-8797
3542a  11/2016 Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement-CDER (Instructions)  (PDF - 133KB) Kendra Stewart
240-402-8797
3613b  09/2018 Supplementary Information Certificate of a Pharmaceutical Product (PDF)  (PDF - 1.2MB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5637
3613f  05/2018 Request for Certificate of a Pharmaceutical Product for CDER Products (PDF)  (PDF - 1.2MB) CDER Export Certificate Program
3664  03/2011 My Medicine Record (PDF) **Note: For best form functionality, Right-click 3664 link and click Save Link As… to save to your desktop and then open the file  (PDF - 466KB) Kris Baumgartner
240-402-4194
3674  07/2017 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 - 153KB) Patrick McNeilly
301- 796-2941
3674  04/2018 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov (PDF)  (PDF - 2.6MB) Patrick McNeilly
301- 796-2941
3792  12/2015 Biosimilar User Fee Cover Sheet (HTML)  (HTM - 0KB) CDER Collections at 301.796.7900
3794  08/2013 Generic Drug User Fee Cover Sheet (Instructions)  (PDF - 650KB) CDER Collections at 301.796.7900
3794  02/2016 Generic Drug User Fee Cover Sheet (HTML)  (HTM - 0KB) CDER Collections at 301.796.7900
3800  10/2014 FDA Safety Reporting Portal (HTML)  (HTM - 0KB) MEDWATCH
1-800-FDA-1088
3908  09/2016 Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request (PDF)  (PDF - 1.7MB) CDER Collections
3911  05/2017 Drug Notification to FDA (PDF) **Note: For best form functionality, Right-click 3911 link and click Save Link As… to save to your desktop and then open the file. (Recommended for use with Adobe Acrobat or Pro)**  (PDF - 2.1MB) Drug Notifications
3911  05/2017 Drug Notification to FDA (Instructions Supplement)  (PDF - 162KB) Drug Notifications
3913  11/2018 User Fee Payment Refund Request (PDF)  (PDF - 2.1MB) CDER Collections at 301-796-7900
3914  11/2018 User Fee Payment Transfer Request (PDF)  (PDF - 2.1MB) CDER Collections at 301-796-7900
3926  07/2017 Individual Patient Expanded Access Investigational New Drug Application (IND) (PDF)**Note: For best form functionality, Right-click 3926 link and click Save Link As… to save to your desktop and then open the file.  (PDF - 2.1MB) CDER Drug Info at 301-796-3400
3926  04/2017 Individual Patient Expanded Access Investigational New Drug Application (IND) (instructions)  (PDF - 155KB) CDER Drug Info at 301-796-3400
3971  12/2016 Small Business Waiver and Refund Request (PDF)  (PDF - 2.1MB) Paul Gibney
240-402-4803
3971  01/2017 Small Business Waiver and Refund Request (Instructions)  (PDF - 217KB) Paul Gibney
240-402-4803
4002  02/2018 CDER Patient Stakeholders Meeting Request (HTML)  (HTM - 0KB) Chris Melton
301-796-7381
4035  01/2018 FDA Orphan Drug Designation Request (PDF)  (PDF - 3.2MB) Yadira Batista-Colon
301-796-8660

Page Last Updated: 12/20/2018
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