News Archive of FDA Vaccines, Blood and Biologics - What\'s New

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Summary Basis for Regulatory Action, June 2, 2014 - Ruconest04-09-15
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine03-25-15
Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products03-23-15
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 201403-23-15
Guidance for Industry: BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System03-23-15
EVITHROM03-23-15
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry03-23-15
ARTISS03-20-15
Component of Erytype S03-17-15
Approval History, Letters, Reviews and Related Documents - Eloctate03-03-15
Package Insert and Patient Information - Rotarix03-02-15
Biologics PREA Reviews and Labeling Changes02-24-15
Biologics Guidances02-24-15
Generics02-24-15
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Draft Guidance02-19-15
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 - Draft02-18-15
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 201502-10-15
Officer/ Employee List for STN 125478/0, RAGWITEK05-09-14
Summary Basis for Regulatory Action - ALPROLIX04-16-14
CBER FY 2013 Recall Posting04-03-14
Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.02-26-14
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus02-24-14
Summary Basis for Regulatory Action, December 22, 2013 - Tretten01-14-14
November 5, 2013 Approval Letter - Cervarix11-07-13
Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria11-05-13
October 25, 2013 Approval Letter - Menactra10-29-13
Osiris Therapeutics, Inc. - Untitled Letter10-21-13
Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot 4030026 Through October 31, 201410-16-13
September 23, 2013 Approval Letter - GAMMAGARD S/D09-25-13
Dosing Decrease to 1.0 mL/kg (50 mg/kg) and Expiration Date Extension for Botulism Immune Globulin Intravenous (Human) (BIG-IV) Lot 5 to March 02, 2015.09-25-13
September 5, 2013 Approval Letter - Gardasil09-13-13
August 27, 2013 Approval Letter - Agriflu08-30-13
FluLaval Quadrivalent08-27-13
August 16, 2013 Approval Letter - FluLaval08-20-13
Summary Basis for Regulatory Action (BLA/STN# 125300/226)08-19-13
Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients08-15-13
Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies07-18-13
Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.06-10-13
CBER-Regulated Products: Shortages and Discontinuations06-18-13
BK130006 Letter06-27-13
Approval History, Letters, Reviews, and Related Documents - BAT06-26-13
June 7, 2013 Approval Letter - Fluzone Quadrivalent06-11-13
Fluzone Quadrivalent06-11-13
Kcentra (Prothrombin Complex Concentrate, Human)05-16-13
Kcentra (Prothrombin Complex Concentrate (Human))05-13-13
Phlebotomy System 1.0.005-09-13
Indication For Use - SOLX System05-09-13
Urgent Medical Device Recall / Field Safety Notice - Micro SSP DNA Typing Trays04-04-13
Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility03-26-13
Public Workshop: Statistical Process Controls for Blood Establishments - Transcripts11-30-12
Draft Agenda - Day 111-29-12
Topic I: Labeling of Red Blood Cell Units with Historical Antigen Type Results Reference Document11-29-12
Topic I: Labeling of Red Blood Cell Units with Historical Antigen Typing Results11-29-12
November 29, 2012: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement: Final Roster11-27-12
December 5, 2012: Blood Products Advisory Committee: Errata ? FDA Briefing Document11-26-12
December 4-5, 2012: Blood Products Advisory Committee Meeting: Briefing Document11-26-12
December 4-5, 2012: Blood Products Advisory Committee Meeting: Draft Agenda11-26-12
Evolving data mining system is designed to speed identification of adverse events following vaccinations12-04-12
December 4-5, 2012: Blood Products Advisory Committee Meeting Roster12-03-12
Blood Products Advisory Committee Meeting December 5 Final Agenda12-03-12
Jobs at the Center for Biologics Evaluation and Research (CBER)12-07-12
EVARREST (Fibrin Sealant Patch)12-06-12
Complete List of Currently Approved NDA and ANDA Application Submissions11-08-12
Complete List of Currently Approved Premarket Approvals (PMAs)11-08-12
Complete List of Substantially Equivalent 510(k) Device Applications11-08-12
Complete List of Currently Approved NDA and ANDA Application Submissions11-08-12
Complete List of Currently Approved Premarket Approvals (PMAs)11-08-12
Complete List of Substantially Equivalent 510(k) Device Applications11-08-12
Biologic Product Shortages11-05-12
Exceptions and Alternative Procedures Approved Under 21 CFR 640.12011-14-12
Fluarix11-09-12
Fluarix11-09-12
Complete List of Currently Approved NDA and ANDA Application Submissions11-08-12
Complete List of Currently Approved Premarket Approvals (PMAs)11-08-12
Complete List of Substantially Equivalent 510(k) Device Applications11-08-12
Biologic Product Shortages11-05-12
Exceptions and Alternative Procedures Approved Under 21 CFR 640.12011-14-12
DailyChek QC Kit10-12-12
AMICUS Separator System; ALYX Component System10-10-12
Ducord, HPC Cord Blood10-05-12
Important Product Information ? Evicel and Evithrom10-01-12
Important Product Information – Evicel and Evithrom10-01-12
BK120036 Letter09-28-12
Final Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.09-25-12
September 14, 2012 Approval Letter - Prevnar 1309-17-12
September 14, 2012 Approval Letter - Imovax09-17-12
Extension of Expiration Date for Black Widow Spider Antivenin Lot 0667018 (in packaged lot 0585Z) until February 12, 2013 And Instructions for Diluent Use08-16-12
Black Widow Spider Antivenin (Latrodectus mactans)(Equine) Packaged Lot 0585Z: Information about Expiration Date and Use08-09-12
Cord Blood Banking - Information for Consumers07-23-12
Package Insert - Twinrix07-19-12
Direct Recall Classification Program06-27-12
Draft Guidance for Industry: Amendment to Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products06-07-12
Procleix Ultrio Plus Assay06-01-12
Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product ?Nakaochi Scrape? associated with a multistate outbreak of Salmonella Bareilly infections04-14-12
Multi-Center Fellowship in Regenerative Medicine04-13-12
FDA Webinar on Safety of the Blood Supply04-04-12
WinRho SDF Liquid03-23-12
Flebogamma DIF 5%03-15-12
Cord Blood Banking Information for Consumers12-09-11
Cord Blood Banking – Information for Consumers12-02-11
Cord Blood Banking â??? Information for Consumers12-02-11
Influenza Virus Vaccine for the 2011 - 2012 Season07-13-11
Fluzone, Fluzone High-Dose and Fluzone Intradermal05-12-11
April 8, 2011 Approval Letter-RotaTeq04-13-11
April 5, 2011 Approval Letter - Gardasil04-12-11
December 1, 2010 Approval Letter - Boostrix03-31-11
March 24, 2011 Approval Letter - Zostavax03-28-11
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral03-17-11
February 24, 2011 Approval Letter - Rotarix03-03-11
February 11, 2011 Approval Letter - Adacel02-17-11
February 2, 2011 Approval Letter - FEIBA02-08-11
February 2, 2011 Approval Letter -Prevnar 1302-08-11
February 2, 2011 Approval Letter - Prevnar 1302-07-11
January 28, 2011 Approval Letter - Menevo02-04-11
Pneumococcal Vaccine, Polyvalent02-02-11
SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities01-20-11
January 13, 2011 Approval Letter - DECAVAC01-20-11
January 13, 2011 Approval Letter - Cervarix01-19-11
December 23, 2010 Approval Letter - Engerix-B01-04-11
December 1, 2010 Approval Letter - Boostix12-09-10
Cord Blood Banking ? Information for Consumers12-08-10
Cord Blood Banking – Information for Consumers12-08-10
Cord Blood Banking ? Information for Consumers, December 7, 201012-07-10
Cord Blood Banking – Information for Consumers, December 7, 201012-07-10
October 25, 2010 Approval Letter - Alphanate11-30-10
November 4, 2010 Approval Letter - Menveo11-15-10
November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee Briefing Document Pathway to Licensure for Protective Antigen-based Anthrax Vaccines for a Post-exposure Prophylaxis Indication Using the Animal Rule11-03-10
Influenza Virus Vaccine for the 2010-2011 Season10-20-10
October 8, 2010 Approval Letter - Agriflu10-18-10
October 13, 2010 Approval Letter - Varivax10-14-10
September 17, 2010 Approval Letter - Rotarix09-20-10
August 30, 2010 Clarification Letter - Afluria09-03-10
August 26, 2010 Approval Letter - Infanrix09-02-10
August 23, 2010 Approval Letter - Havrix08-31-10
August 23, 2010 Approval Letter - Engerix-B08-31-10
August 24, 2010 Approval Letter - Fluvirin08-26-10
URGENT - Voluntary Market Withdrawal of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation08-24-10
July 19, 2010 Approval Letter - Fluarix08-17-10
Recall of Panoscreen lll08-10-10
AFLURIA07-30-10
FluMist07-27-10
Medical Device Recall: Cobe Spectra Apheresis System Disposable Tubing Sets07-16-10
GLASSIA07-01-10
CSL Biotherapies Untitled Letter06-25-10
June 2, 2010 Approval Letter - Havrix06-24-10
June 2, 2010 Approval Letter - Engerix06-24-10
7345.848 - Inspection of Biological Drug Products06-22-10
Urgent Medical Device Removal: HIV-1 MONITOR Test, v1.506-18-10
May 19, 2010 Approval Letter - Kinrix06-15-10
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products05-27-10
Omrix Biopharmaceuticals Ltd Untitled Letter05-25-10
Easy Kit Info and Http Eu Hiv Test - Untitled Letter05-21-10
May 5, 2010 Approval Letter - Cervarix05-19-10
Information for Health Care Professionals: Anticipated Short Supply of Coral Snake Antivenom (Pfizer Inc. )05-18-10
Menveo - Untitled Letter05-18-10
Fluarix05-14-10
Drug Master Files for CBER-Regulated Products05-11-10
Regulatory Submissions in Electronic Format for Biologic Products05-11-10
Kogenate FS05-05-10
FluLaval05-05-10
TachoSil05-05-10
Abbott Prism Chagas05-05-10
Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments04-12-10
Vaqta04-09-10
Fluzone and Fluzone High-Dose03-03-10
Infanrix02-24-10
NovoSevenRT02-23-10
DIA/FDA CDER/CBER Computational Science Annual Meeting03-04-10
Hizentra03-04-10
Biologic Product Shortages10-20-08
Cord Blood Licensure: A Workshop01-27-10
Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating01-15-10
COBAS TaqScreen MPX Test08-10-09
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Questions and Answers01-13-10
Fast Track Designation Request Performance03-18-09
Pentacel07-17-09
InterSol Solution/Platelet Additive Solution 312-10-09
Biologics Sentinel Initiative Projects01-05-10
2009 Biological Device Application Approvals09-08-09
2009 Biological License Application Supplement Noteworthy Approvals07-14-09
Havrix03-03-09
Engerix-B03-03-09
Clinical Investigator Status (Biologics)06-16-09
List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)06-08-09
Fluzone03-06-09
Complete List of Currently Approved NDA and ANDA Application Submissions05-09-09
Complete List of Currently Approved Premarket Approvals (PMAs)05-09-09
Complete List of Substantially Equivalent 510(k) Device Applications05-09-09
Twinrix02-25-09
Gammaplex09-18-09
Symphony System 3.012-01-09
Jobs at the Center for Biologics Evaluation and Research (CBER)02-26-09
Exceptions and Alternative Procedures Approved Under 21 CFR 640.12010-18-08
Biologics PREA Reviews and Labeling Changes03-18-09
Clinical Pharmacologist11-30-09
Agriflu11-27-09
2009 Biological License Application Approvals09-08-09
ALBAclone (Alba Bioscience Limited)11-19-09
Zostavax04-22-09
Research Technician (Interdisciplinary)10-28-09
Influenza Virus Vaccine Actions09-03-09
InterSol Solution/ Platelet Additive Solution 312-10-09
Procleix Ultrio Assay02-19-09
Influenza Virus Vaccine for the 2009-2010 Season05-28-09
Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release09-15-09
Public Workshop: Emerging Arboviruses: Evaluating the Threat to Transfusion and Transplantation Safety10-27-09
Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics02-19-09
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act03-18-09
Wilate12-05-09
Symphony System  3.012-01-09
Test Result Interface for ElDorado Donor12-07-09