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In this section: Biologics Procedures (SOPPs)

Section 8400: Marketing Applications

SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
Effective Date: January 8, 2024

SOPP 8401.1: Issuance of and Review of Responses to Information Request Communications to Pending Applications
Effective Date: October 1, 2022

SOPP 8401.2: Administrative Processing of BLA and NDA Supplements
Effective Date: February 8, 2024

SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications, New Drug Applications and Supplements
Effective Date: October 1, 2022

SOPP 8401.7 - Action Package for Posting
Effective Date: February 27, 2022

SOPP 8402: Designation of Amendments as Major
Effective Date: October 10, 2024

SOPP 8403: Issuance, Reissuance, and Voluntary Revocation of Biological Products Licenses
Effective Date: February 27, 2023

SOPP 8404: Refusal to File Procedures
Effective Date: August 29, 2024

SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest)
Effective Date: September 7, 2023

SOPP 8405.1: Procedures for Resubmissions to an Application or Supplement
Effective Date: November 13, 2022

SOPP 8406: CBER Processing of PDUFA Application Payments
Effective Date: October 1, 2022

SOPP 8407: Compliance Status Checks
Effective Date: December 11, 2020

SOPP 8408.1: Development of Laboratory Quality Product Testing Plans and Release of Lots as Part of the BLA Approval Process
Effective Date: August 24, 2022

SOPP 8408.3: Lot Release Activities for Licensed Biological Products
Effective Date: September 25, 2019

SOPP 8410: Determining When Pre-License / Pre-Approval Inspections are Necessary
Effective Date: January 6, 2020

SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Applications (BLAs)
Effective Date: December 11, 2020

SOPP 8412 - Review of Product Labeling
Effective Date: December 11, 2020

SOPP 8413: Postmarketing Requirement/Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting
Effective Date: February 15, 2024

SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments
Effective Date: February 15, 2024

SOPP 8416: CBER Intiated Second Level STNs
Effective Date: February 27, 2012

SOPP 8417: Implementation and Management of Risk Evaluation and Mitigation Strategies (REMS)
Effective Date: October 1, 2022

SOPP 8419: Section 505(o)(4) Required Safety Labeling Changes (SLCs)
Effective Date: February 12, 2024

SOPP 8420: FDAAA Section 921 - Posting of Potential Signals of Serious Risk
Effective Date: February 27, 2022

SOPP 8421: Complying with Requirements under the Pediatric Research Equity Act (PREA)
Effective Date: February 27, 2023

SOPP 8422: Processing and Review of Trans-BLA Submissions
Effective Date: February 27, 2023

SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes
Effective Date: July 31, 2024

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