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  4. Biologics Procedures (SOPPs)
  5. Section 8400: Marketing Applications
  1. Biologics Procedures (SOPPs)

Section 8400: Marketing Applications

SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
Effective Date: October 1, 2017

SOPP 8401.1: Issuance of and Review of Responses to Information Request Communications and Discipline Review Letters to Pending Applications
Effective Date: February 1, 2018

SOPP 8401.2: Administrative Processing of BLA and NDA Supplements
Effective Date: August 26, 2019

SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications and Supplements
Effective Date: March 19, 2019

SOPP 8401.7 - Action Package for Posting
Effective Date: September 1, 2019

SOPP 8402: Designation of Amendments as Major
Effective Date: October 1, 2017

SOPP 8403: Issuance and Reissuance of Licenses for Biological Products
Effective Date: September 21, 2010

SOPP 8404: Refusal to File Procedures
Effective Date: March 12, 2018

SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest)
Effective Date: January 2, 2004

SOPP 8405.1: Procedures for Resubmissions of an Application or Supplement
Effective Date: October 1, 2012

SOPP 8406: CBER Processing of PDUFA Application Payments
Effective Date: September 24, 2019

SOPP 8407: Compliance Status Checks
Effective Date: November 28, 2006

SOPP 8408.1: Development of Testing Plans and Release of Lots as Part of the Approval Process
Effective Date: March 7, 2017

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: September 4, 2018

SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Applications (BLAs)
Effective Date: June 1, 2011

SOPP 8412 - Review of Product Labeling
Effective Date: June 18, 2018

SOPP 8413: Postmarketing Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting
Effective Date: April 10, 2017

SOPP 8414: Fast Track Drug Development Programs: Designation and Review Programs
Effective Date: November 16, 2001

SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments
Effective Date: August 26, 2019

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

SOPP 8420: FDAAA Section 921 - Posting of Potential Signals of Serious Risk
Effective Date: September 17, 2019

SOPP 8422: Processing Trans-BLA Submissions
Effective Date: April 18, 2011

SOPP 8426: Assignment of Biological Product Proper Names
Effective Date: April 10, 2019

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