Manufacturers Assistance and Technical Training Branch (MATTB)
CBER ’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide timely, accurate and useful information to stakeholders. (Source: What's New at CBER)
Source: What's New at CBER - June 6, 2018 Category: Biomedical Science Source Type: news

CBER-Regulated Products: Shortages and Discontinuations
A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand. (Source: What's New at CBER)
Source: What's New at CBER - March 28, 2018 Category: Biomedical Science Source Type: news

SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)
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 - March 27, 2018 Category: Biomedical Science Source Type: news

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
List of Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) products (Source: What's New at CBER)
Source: What's New at CBER - March 26, 2018 Category: Biomedical Science Source Type: news

Direct Recall Classification Program
CBER's Direct Recall Classification (DRC) program provides establishments the opportunity to electronically report recall related information directly to CBER. (Source: What's New at CBER)
Source: What's New at CBER - March 23, 2018 Category: Biomedical Science Source Type: news

Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood
(Source: What's New at CBER)
Source: What's New at CBER - March 23, 2018 Category: Biomedical Science Source Type: news

Cord Blood Banking - Information for Consumers
(Source: What's New at CBER)
Source: What's New at CBER - March 23, 2018 Category: Biomedical Science Source Type: news

Osiris Therapeutics, Inc. - Untitled Letter
(Source: What's New at CBER)
Source: What's New at CBER - March 23, 2018 Category: Biomedical Science Source Type: news

CBER ’s Sentinel Program
(Source: What's New at CBER)
Source: What's New at CBER - March 22, 2018 Category: Biomedical Science Source Type: news

CBER ’ s Sentinel Program
(Source: What's New at CBER)
Source: What's New at CBER - March 22, 2018 Category: Biomedical Science Source Type: news

September 23, 2013 Approval Letter - GAMMAGARD S/D
. (Source: What's New at CBER)
Source: What's New at CBER - March 6, 2018 Category: Biomedical Science Source Type: news

Zoster Vaccine, Live
(Source: What's New at CBER)
Source: What's New at CBER - March 1, 2018 Category: Biomedical Science Source Type: news

Yellow Fever Vaccine
CBER Approved Product For active immunization of persons 9 months of age and older who: •Are living in or traveling to endemic areas; •Travelling internationally to countries that require evidence of vaccination from entering travelers or; •Laboratory Personnel who might be expose to virulent yellow fever virus or to concentrated preparations of the yellow fever vaccine strain b y direct or indirect contact or by aerosols should by vaccinated. (Source: What's New at CBER)
Source: What's New at CBER - March 1, 2018 Category: Biomedical Science Source Type: news

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
(Source: What's New at CBER)
Source: What's New at CBER - March 1, 2018 Category: Biomedical Science Source Type: news

Smallpox (Vaccinia) Vaccine, Live
(Source: What's New at CBER)
Source: What's New at CBER - March 1, 2018 Category: Biomedical Science Source Type: news

Pneumococcal Vaccine, Polyvalent
(Source: What's New at CBER)
Source: What's New at CBER - February 27, 2018 Category: Biomedical Science Source Type: news

Gamunex-C
(Source: What's New at CBER)
Source: What's New at CBER - February 26, 2018 Category: Biomedical Science Source Type: news

Flebogamma DIF 5% & 10%
Updated Package Insert, December 2009. (Source: What's New at CBER)
Source: What's New at CBER - February 26, 2018 Category: Biomedical Science Source Type: news

DigiFab
Product approval information is indicated for Treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. (Source: What's New at CBER)
Source: What's New at CBER - February 23, 2018 Category: Biomedical Science Source Type: news

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