Vaccines, Blood & Biologics
-
Section 8400: Marketing Applications
-
- SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
Effective Date: April 25, 2013 - SOPP 8401.1: Issuance of and Review of Responses to Information Request Communications and Discipline Review Letters to Pending Submissions
Effective Date: November 15, 2012 SOPP 8401.2: Administrative Processing of Biologics License Application Supplements (BLSs) [Except Blood, Blood Components, and Source Plasma]
Effective Date: May 11, 2003SOPP 8401.3: Filing Action: Communication Options
Effective Date: August 4, 2010SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications and Supplements
Effective Date: April 8, 2005SOPP 8401.6: The Responsibilities of the Division of Epidemiology (DE/OBE) in the BLA Review Process
Effective Date: August 27, 2007SOPP 8401.7: Action Package for Posting
Effective Date: December 5, 2011SOPP 8402: Designation of Amendments as Major
Effective Date: October 1, 2012SOPP 8403: Issuance and Reissuance of Licenses for Biological Products
Effective Date: September 21, 2010SOPP 8404: Refusal to File Procedures for Biologic License Applications
Effective Date: August 27, 2007SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest)
Effective Date: January 2, 2004SOPP 8405: Complete Review and Issuance of Action Letters
Effective Date: September 20, 2004- SOPP 8405.1: Procedures for Resubmissions of an Application or Supplement
Effective Date: October 1, 2012 SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities
Effective Date: October 19, 2009SOPP 8407: Compliance Status Checks
Effective Date: November 28, 2006SOPP 8408.1: Development of Testing Plans and Release of Lots as Part of the Approval Process
Effective Date: March 15, 2011SOPP 8410: Determining When Pre-License / Pre-Approval Inspections are Necessary
Effective Date: December 4, 2001SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Applications (BLAs)
Effective Date: June 1, 2011SOPP 8412: Review of Product Labeling
Effective Date: April 2, 2012SOPP 8413: Postmarketing Requirement/Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting
Effective Date: August 25, 2010SOPP 8414: Fast Track Drug Development Programs: Designation and Review Programs
Effective Date: November 16, 2001SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments
Effective Date: September 15, 2008SOPP 8416: CBER Initiated Second Level STNs
Effective Date: February 27, 2012SOPP 8420: FDAAA Section 921: Posting of Potential Signals of Serious Risk
Effective Date: November 1, 2011SOPP 8422: Processing of Trans-BLA Submissions
Effective Date: April 18, 2011
-
-
-
