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Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
(Source: What's New at CBER)
Source: What's New at CBER - February 21, 2018 Category: Biomedical Science Source Type: news

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
(Source: What's New at CBER)
Source: What's New at CBER - February 21, 2018 Category: Biomedical Science Source Type: news

Alphanate
(Source: What's New at CBER)
Source: What's New at CBER - February 15, 2018 Category: Biomedical Science Source Type: news

Advate
(Source: What's New at CBER)
Source: What's New at CBER - February 15, 2018 Category: Biomedical Science Source Type: news

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry
This is the Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry. (Source: What's New at CBER)
Source: What's New at CBER - February 14, 2018 Category: Biomedical Science Source Type: news

NovoSevenRT
(Source: What's New at CBER)
Source: What's New at CBER - February 14, 2018 Category: Biomedical Science Source Type: news

NovoSeven
(Source: What's New at CBER)
Source: What's New at CBER - February 14, 2018 Category: Biomedical Science Source Type: news

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2018
Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2018. (Source: What's New at CBER)
Source: What's New at CBER - January 19, 2018 Category: Biomedical Science Source Type: news

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 System
This is the 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 System. (Source: What's New at CBER)
Source: What's New at CBER - January 5, 2018 Category: Biomedical Science Source Type: news

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 - Guidance for Industry
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 Guidance for Industry. (Source: What's New at CBER)
Source: What's New at CBER - January 5, 2018 Category: Biomedical Science Source Type: news

Regulatory Submissions in Electronic Format for Biologic Products
FDA has started the transition to a more automated electronic review process for these submissions. (Source: What's New at CBER)
Source: What's New at CBER - December 18, 2017 Category: Biomedical Science Source Type: news

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
(Source: What's New at CBER)
Source: What's New at CBER - December 15, 2017 Category: Biomedical Science Source Type: news

Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations
This page is about Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations (Source: What's New at CBER)
Source: What's New at CBER - December 13, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application
This is the Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application. (Source: What's New at CBER)
Source: What's New at CBER - November 29, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria
(Source: What's New at CBER)
Source: What's New at CBER - November 24, 2017 Category: Biomedical Science Source Type: news

Drug Master Files for CBER-Regulated Products
(Source: What's New at CBER)
Source: What's New at CBER - November 21, 2017 Category: Biomedical Science Source Type: news

SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)- pdf
This is the CBER SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA). (Source: What's New at CBER)
Source: What's New at CBER - November 20, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry and FDA Staff: IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b):  Questions and Answers Regarding the Scope of the Exception
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff
This is a Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff (Source: What's New at CBER)
Source: What's New at CBER - October 13, 2017 Category: Biomedical Science Source Type: news

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry
This is the Draft Guidance for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry (Source: What's New at CBER)
Source: What's New at CBER - October 13, 2017 Category: Biomedical Science Source Type: news

Package Insert - TWINRIX
(Source: What's New at CBER)
Source: What's New at CBER - October 3, 2017 Category: Biomedical Science Source Type: news

SOPP 8406: CBER Processing of PDUFA Application Payments
This document describes the procedures used to determine the accuracy of information submitted by an applicant and to verify user fee payments relative to the Prescription Drug User Fee Act (PDUFA) of 1992, as reauthorized by the Food and Drug Administration Amendments Act of 2007. In addition, this document identifies other user fee activities for which the Office of Management ’s Regulatory Information Management Staff (RIMS) is responsible. (Source: What's New at CBER)
Source: What's New at CBER - September 29, 2017 Category: Biomedical Science Source Type: news

Anti-B (Murine Monoclonal)
(Source: What's New at CBER)
Source: What's New at CBER - September 28, 2017 Category: Biomedical Science Source Type: news

Privigen
(Source: What's New at CBER)
Source: What's New at CBER - September 18, 2017 Category: Biomedical Science Source Type: news

Abbott Prism Chagas
The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens. (Source: What's New at CBER)
Source: What's New at CBER - September 11, 2017 Category: Biomedical Science Source Type: news

WinRho SDF Liquid
Updated Package Insert, Patient Information and " Dear Healthcare Provider " Letter with Drug Warning Information. Updated: January 26, 2010. (Source: What's New at CBER)
Source: What's New at CBER - September 8, 2017 Category: Biomedical Science Source Type: news

Diphtheria and Tetanus Toxoids Adsorbed
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news

Benefix
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news

ReFacto
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news

TachoSil
(Source: What's New at CBER)
Source: What's New at CBER - August 24, 2017 Category: Biomedical Science Source Type: news

FluLaval Quadrivalent
(Source: What's New at CBER)
Source: What's New at CBER - July 13, 2017 Category: Biomedical Science Source Type: news

EVARREST (Fibrin Sealant Patch)
(Source: What's New at CBER)
Source: What's New at CBER - July 5, 2017 Category: Biomedical Science Source Type: news

Biologics Guidances
(Source: What's New at CBER)
Source: What's New at CBER - July 3, 2017 Category: Biomedical Science Source Type: news

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2017
Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2017. (Source: What's New at CBER)
Source: What's New at CBER - July 3, 2017 Category: Biomedical Science Source Type: news

Seraclone Blood Grouping Reagent Anti-S (Monoclonal)
(Source: What's New at CBER)
Source: What's New at CBER - June 26, 2017 Category: Biomedical Science Source Type: news

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)
(Source: What's New at CBER)
Source: What's New at CBER - June 20, 2017 Category: Biomedical Science Source Type: news

ABBOTT HIVAB HIV-1/HIV-2 (rDNA) EIA
HIVAB HIV-1/HIV-2 (rDNA) EIA is an in vitro enzyme immunoassay for the qualitative detection of antibodies to human immunodeficiency viruses type 1 and/or type 2 (HIV-1/HIV-2) in human serum, plasma, or cadaveric serum (Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

COBAS TaqScreen West Nile Virus Test
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

Procleix West Nile Virus (WNV) Assay
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

Auszyme Monoclonal
CBER Auszyme Monoclonal Product Approval Information (Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

Procleix HIV-1/HCV Assay
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

ORTHO T. cruzi ELISA Test System
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Vaccine lot release information updated on 3/3/2010. (Source: What's New at CBER)
Source: What's New at CBER - May 31, 2017 Category: Biomedical Science Source Type: news

Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients
(Source: What's New at CBER)
Source: What's New at CBER - May 31, 2017 Category: Biomedical Science Source Type: news