What’s New for Biologics

What’s New for Biologics

• October 19, 2018 Approval Letter - Varivax (PDF - 102KB) 
  Posted: 10/22/2018
• BK180229 - HemoMix 3 with DCSX Software 
  Posted: 10/22/2018
• Influenza Virus Vaccine for the 2018-2019 Season 
  Updated: 10/18/2018
• CBER-Regulated Products: Current Shortages 
  Posted: 10/18/2018; Information on Immune Globulin Intravenous (Human) - Gammaplex
• Summary of Safety and Effectiveness Data - ID CORE XT (PDF - 524KB) 
  Posted: 10/17/2018
• BK180227 - VistA Blood Establishment Computer (VBECS) Version 2.3.0 
  Posted: 10/16/2018
• BK180226 - IH-Com V5.0 
  Posted: 10/16/2018
• BK180225 - IH-Reader 24 
  Posted: 10/16/2018
• Clinical Investigator Status (Biologics) 
  Posted: 10/16/2018; Updated through 9/30/2018
• Clinical Review - COAGADEX (PDF - 567KB) 
  Updated: 10/15/2018
• October 11, 2018 Untitled Letter - Registrant of www.ollereg.com (PDF - 42KB) 
  Posted: 10/15/2018
• October 11, 2018 Approval Order - ID CORE XT (PDF - 54KB) 
  Posted: 10/12/2018
• Statistical Review - Afluria Quadrivalent(125254-692) (PDF - 533KB) 
  Posted: 10/11/2018
• Statistical Review Addendum - Afluria Quadrivalent ( 125254-692) (PDF - 256KB) 
  Posted: 10/11/2018
• Clinical Review - Afluria Quadrivalent (125254-692) (PDF - 1.1MB)
  Posted: 10/11/2018
• October 3, 2018 Summary Basis for Regulatory Action- Afluria Quadrivalent (PDF - 235KB) 
  Posted: 10/11/2018
• Influenza Virus Vaccine for the 2018-2019 Season 
  Updated: 10/11/2018
• October 5, 2018 Summary Basis of Regulatory Action - GARDASIL 9 (PDF - 86KB) 
  Updated: 10/10/2018
• October 2, 2018 Summary Basis of Regulatory Action - IXIARO (PDF - 117KB) 
  Updated: 10/10/2018
• October 4, 2018 Approval Letter - Afluria and Afluria Quadrivalent (PDF - 103KB) 
  Updated: 10/10/2018
• 2018 Biological License Application Supplement Noteworthy Approvals 
  Posted: 10/10/2018; Updated through 9/30/2018
• 2018 Biological Device Application Approvals 
  Posted: 10/10/2018; Updated through 9/30/2018
• October 5, 2018 Approval Letter - Gardasil 9 (PDF - 36KB) 
  Posted: 10/5/2018
• October 4, 2018 Approval Letter - Menveo (PDF - 34KB) 
  Posted: 10/5/2018
• CBER FY 2018 Recall Postings 
  Posted: 10/4/2018
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB) 
  Posted: 10/4/2018; Updated through 9/30/2018
• Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 37KB) 
  Posted: 10/4/2018; Updated through 9/30/2018
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 747KB) 
  Posted: 10/4/2018; Updated through 9/30/2018
• Complete List of Licensed Products and Establishments 
  Posted: 10/4/2018; Updated through 9/30/2018
• Influenza Virus Vaccine for the 2018-2019 Season 
  Updated: 10/4/2018
• October 4, 2018 Approval Letter - IXIARO (PDF - 35KB) 
  Posted: 10/4/2018
• CBER Secure Email Policy Takes Effect October 1, 2018 
  Updated: 10/2/2018
• Recall Notification to Clients with Possible Product On-Hand, Effective 9/28/18 
  Posted: 10/1/2018
• INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products) 
  Updated: 10/1/2018
• SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products (PDF - 78KB) 
  Posted: 10/1/2018
• Biological Product Deviation Reporting - Blood Product Codes (PDF - 21KB) 
  Updated: 9/28/2018
• Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes (PDF - 311KB) 
  Updated: 9/28/2018
• Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes (PDF - 264KB) 
  Updated: 9/28/2018
• Briefing Document - World Health Organization Web Links for 153rd VRBPAC Meeting - October 3, 2018 
  Updated: 9/28/2018
• CBER Secure Email Policy Takes Effect October 1, 2018 
  Updated: 9/28/2018
• SOPP 8117: Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format (PDF - 101KB) 
  Updated: 9/28/2018
• SOPP 8119: Use of Email for Regulatory Communications (PDF - 376KB) 
  Updated: 9/28/2018
• Influenza Virus Vaccine for the 2018-2019 Season 
  Updated: 9/27/2018
• Manufacturers Assistance and Technical Training Branch (MATTB)
  Updated: 9/27/2018; "How to Search the Code the Federal Regulations on FDA's website." within MATTB Learn
• September 21, 2018 Approval Letter - COAGADEX (PDF - 35KB) 
  Posted: 9/25/2018
• Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry (PDF - 97KB) 
  Posted: 9/24/2018
• Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry (PDF - 434KB) 
  Posted: 9/24/2018
• BER Instructions for Completing the Electronic Blood Establishment Registration and Product Listing Form (PDF - 96KB)
  Updated: 9/24/2018