Biologics; Licensing; General Biological Products Standards; and Additional Standards

Biologics License Applications; Procedures & Requirements

OMB: 0910-0338

IC ID: 5935

Documents and Forms

Document Name Document Type
Form Form FDA 2253 Biologics; Licensing; General Biological Products Standards; and Additional Standards Form and Instruction
0338 BLAs GFI for Cooperative MFR Arrangements NOV 2008.pdf www.fda.gov/media/70712/download Other-Agency Guidance
0338 BLAs GFI for Cooperative MFR Arrangements NOV 2008.pdf www.fda.gov/media/70712/download Other-Agency Guidance
FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf Instruction
FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf Instruction
FDA-3988_Instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx Instruction
FDA-3988_Instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx Instruction
FDA-3989_instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx Instruction
FDA-3989_instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx Instruction
Form FDA 3674 Certification of Compliance Instructions.pdf Instruction
Form FDA 3674 Certification of Compliance Instructions.pdf Instruction
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING F FDA Form 2253.pdf Form and Instruction
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING F FDA Form 2253.pdf Form and Instruction
Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO FORM FDA 2252 SUPPLEMENT.pdf Form and Instruction
Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO FORM FDA 2252 SUPPLEMENT.pdf Form and Instruction
Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO FDA 2252.pdf Form
Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO FDA 2252.pdf Form
FDA 356h Application to Market a New Drug or Abbreviated New Drug Form FDA 356h with comments noting changes Aug 2022.pdf Form
FDA 356h Application to Market a New Drug or Abbreviated New Drug Form FDA 356h with comments noting changes Aug 2022.pdf Form
FDA 3988 Transmittal of PMR/PMC Submissions for Drugs and Biologi FDA-3988_Dyn_Sec_Ext_09-02-22.pdf Form
FDA 3988 Transmittal of PMR/PMC Submissions for Drugs and Biologi FDA-3988_Dyn_Sec_Ext_09-02-22.pdf Form
FDA 3989 PMR/PMC Annual Status Report for Drugs and Biological Pr Draft_FDA-3989_Dyn_Sec_Ext_09-02-22 (002).pdf Form
FDA 3989 PMR/PMC Annual Status Report for Drugs and Biological Pr Draft_FDA-3989_Dyn_Sec_Ext_09-02-22 (002).pdf Form
FDA 3674 Certification of Compliance FDA-3674 Certification of Compliance.pdf Form
FDA 3674 Certification of Compliance FDA-3674 Certification of Compliance.pdf Form