Subpart B - Applications

Applications for FDA Approval to Market a New Drug

OMB: 0910-0001

IC ID: 5662

Documents and Forms

Document Name Document Type
Form FDA 3331a Subpart B - Applications Form and Instruction
FDA 3331a NDA - Field Alert Report Form FDA 3331a DRAFT FEB 2020.pdf www.fda.gov/drugs/surveillance/field-alert-reports Form and Instruction
FDA 2252 Transmittal of annual drug and biologic report under 314.81 FDA 2252 reports rev 2021.pdf Form
2252 instructions rev 2021.pdf Instruction
FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE Form FDA 2253 propchanges 9-9-2021.pdf Form
FDA-2253-Instructions rev 2021.pdf Instruction
PDUFA Committment Goals.pdf Other-Performance Goals
FDARA 2017.pdf Other-Legislative Authority
21 USC 355 New Drugs.pdf Other-Statutory Authority
FDA 356h Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use Form FDA 356h with comments noting changes Aug 2022.pdf Form
FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf Instruction
FDA 3542a Patent Information Submitted with an NDA, or Supplement 0001 Form FDA 3542a_Dyn_Sec_Ext_07-17-2023.pdf Form
Form FDA 3542a instructions_07-18-2023.pdf Instruction
FDA 3542 Patent Information Submitted Upon and After Approval of an NDA or Supplement 0001 Form FDA 3542_Dyn_Sec_Ext_07-17-2023.pdf Form
0001 Form FDA 3542_instructions_07-17-2023.pdf Instruction