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Vaccines, Blood & Biologics
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Section 8400: License Applications
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- SOPP 8401: Administrative Processing of Biologics License Application (BLA)
Effective Date: May 1, 2007 - SOPP 8401.1: Issuance and Review of Responses to Information Requests and Discipline Review Letters to Pending Applications
Effective Date: Date: June 11, 2002 - SOPP 8401.2: Administrative Processing of Biologics License Application Supplements (BLSs) [Except Blood, Blood Components, and Source Plasma]
Effective Date: Date: May 11, 2003 - SOPP 8401.3: Filing Action: Communication Options
Effective Date: May 11, 2003 - SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications and Supplements
Effective Date: April 8, 2005 - SOPP 8401.5: Processing of Animal Component Information Submitted in Investigational and Marketing Applications / Notifications
Effective Date: June 24, 2005 - SOPP 8401.6: The Responsibilities of the Division of Epidemiology (DE/OBE) in the BLA Review Process
Effective Date: August 27, 2007 - SOPP 8402: Designation of License Application Amendments as Major or Minor
Effective Date: February 12, 2009 - SOPP 8403: Issuance and Reissuance of Licenses for Biological Products
Effective Date: April 6, 1999 - SOPP 8404: Refusal to File Procedures for Biologic License Applications
Effective Date: August 27, 2007 - 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: Complete Review and Issuance of Action Letters
Effective Date: September 20, 2004 - SOPP 8405.1: Procedures for the Classification of Resubmissions of an Application for a Product Covered by the Prescription Drug User Fee Act (PDUFA III)
Effective Date: August 30, 2002 - SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities
Effective Date: Date: October 19, 2009 - SOPP 8407: Compliance Status Checks
Effective Date: Date: November 28, 2006 - SOPP 8408: Collaboration of CBER Offices on Issues Related to the Release Of Pre-Licensing and Routine Lots
Effective Date: November 19, 1996 - SOPP 8410: Determining When Pre-License / Pre-Approval Inspections are Necessary
Effective Date: Date: December 4, 2001 - SOPP 8411.1: Changes to an Approved Application - Administrative Handling and Review of Annual Reports
Effective Date: Date: October 26, 2001 - SOPP 8412: Review of Product Labeling
Effective Date: Date: March 20, 2008 - SOPP 8413: Postmarketing Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting
Effective Date: January 28, 2008 - 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: September 15, 2008 - SOPP 8416: CBER Initiated Second Level STNs
Effective Date: September 12, 2008
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