Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links

Vaccines, Blood & Biologics

-

CBER's Web Based Outreach Program Presentations

The documents below are available in English, French, and Spanish. FDA offers these translations as a service to a broad international audience. We hope that you find these translations useful. While the agency has attempted to obtain translations that are as faithful as possible to the English version, we recognize that the translated versions may not be as precise, clear, or complete as the English version. The official version of these documents is the English version.

Introduction
Karen Midthun, M.D., Director, Center for Biologics Evaluation and Research

Office of the Director
Overview of the Food and Drug Administration and the Center for Biologics Evaluation and Research
CBER Advisory Committees
FDA Laws, Regulations, and Guidance Documents
Good Guidance Practices
Product Jurisdiction
Science at CBER: Why, How, and What?
Addressing Pandemic Influenza Preparedness

Office of Blood Research and Review
FDA Regulation of Blood and Blood Components in the United States
Blood Screening IVDs
Medical Device Review at CBER
Nonclinical Studies for Plasma Derived and Analogous Products
Viral Safety of Plasma-Derived Products
Case Study: Adverse Event Report for an Immune Globulin: FDA Investigation and Actions

Office of Biostatistics and Epidemiology
Evaluation of Biological Product Safety Throughout the Lifecycle at FDA’s Center for Biologics Evaluation and Research

Office of Cellular, Tissue and Gene Therapies
Overview: Office of Cellular, Tissue and Gene Therapies
FDA Regulation of Human Cells and Tissues
Cellular Therapy Products
Combination Product Review Issues
Manufacturing of Gene Therapies: Ensuring Product Safety and Quality
Preclinical Considerations in Cell and Gene Therapy Product Development
Clinical Study Issues in Early Phase Trials of Cell and Gene Therapies

Office Of Compliance And Biologics Quality
Inspections of CBER Regulated Products
Compliance and Product Quality
CBER’s Bioresearch Monitoring Program: Clinical and Nonclinical Inspections
CBER’s Lot Release System: Overview of the Current Process

Office of Vaccines Research and Review
Overview of the Office of Vaccines Research and Review
Regulatory Perspective on Development of Preventive Vaccines for Global Infectious Diseases
Pre-Licensure Review of Preventive Vaccines
Regulatory Considerations in The Safety Assessment of Adjuvants and Adjuvanted Preventive Vaccines
Division of Product Quality

Back to the Top

Introduction

Karen Midthun, M.D.
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

Back to the Top

Office of the Director

Overview of the Food and Drug Administration and the Center for Biologics Evaluation and Research
An overview of the U.S. government framework and its Agencies, with focus on FDA CBER and its regulatory responsibilities.

Back to the Top

CBER Advisory Committees

Overview of the FDA Advisory Committee Program, to include areas under advisement, committee structure, member screening, and public forums.

Back to the Top

FDA Laws, Regulations, and Guidance Documents
Discussion of the legal framework under which FDA operates, regulatory authorities, and FDA guidance documents.

Back to the Top

Good Guidance Practices
Discussion of FDA’s development of draft and final guidance documents.

Back to the Top

Product Jurisdiction
An overview of CBER’s decision process on regulatory responsibility for products within the Center.

Back to the Top

Science at CBER: Why, How, and What?
Detailed discussion of the research programs at CBER, as they relate to the regulatory activities within the Center.

Back to the Top

Addressing Pandemic Influenza Preparedness
Discussion of the 2009 H1N1 pandemic, and includes discussion on licensure of H1N1 vaccines, regulatory pathways for pandemic vaccine licensure, and emergency use authorizations.

Back to the Top

Office of Blood Research and Review

FDA Regulation of Blood and Blood Components in the United States
Overview of the Office of Blood Research and Review, and its regulatory review of blood and blood products, including discussion of in vitro diagnostic devices, Class II and III devices, blood collection, and source plasma.

Back to the Top

Blood Screening IVDs
Discussion on blood screening in vitro diagnostics, including safety, required screening/testing, and a brief discussion on the Investigational New Drug application (IND)/Biologics License Application (BLA) process.

Back to the Top

Medical Device Review at CBER
Detailed discussion on the regulatory process for medical devices at CBER, a review of definitions, explanation of why the Center for Biologics reviews devices, and reporting requirements.

Back to the Top

Nonclinical Studies for Plasma Derived and Analogous Products
Discussion from the Division of Hematology (DH), which includes the review of nonclinical/preclinical studies, toxicity testing, and a description of the DH laboratories.

Back to the Top

Viral Safety of Plasma-Derived Products
Discussion on viral validation studies for plasma-derived products, including viral safety, viral validation and viral clearance.

Back to the Top

Case Study: Adverse Event Report for an Immune Globulin: FDA Investigation and Actions
Discussion of an adverse event case study and the regulatory activities of the Clinical Review Branch in the Division of Hematology, including a description of adverse event reporting systems.

Back to the Top

Office of Biostatistics and Epidemiology

Evaluation of Biological Product Safety Throughout the Lifecycle at FDA’s Center for Biologics Evaluation and Research
Detailed discussion on the safety and surveillance of biological products, including a description of monitoring approaches used at CBER, and pharmacovigilance planning by manufacturers.

Back to the Top

Office of Cellular, Tissue and Gene Therapies

Overview: Office of Cellular, Tissue and Gene Therapies
Overview of the Office of Cellular, Tissue and Gene Therapies, discussion of each regulated product type, outreach, sponsor interaction, and laboratory research.

Back to the Top

FDA Regulation of Human Cells and Tissues
Detailed discussion of the regulation of human cells and tissues, which includes product definitions, requirements for regulation, establishments, donor eligibility, and manufacturer responsibilities.

Back to the Top

Cellular Therapy Products
Detailed discussion on the regulation of cellular therapies, which includes criteria for regulation, unique product challenges, testing methods, potency assays, and product characterization.

Back to the Top

Combination Product Review Issues
Review of biologic combination products, with specific examples of cellular therapy-device combination product scenarios.

Back to the Top

Manufacturing of Gene Therapies: Ensuring Product Safety and Quality
Detailed discussion on the regulation of gene therapy products and manufacturing, including other replicating products, to ensure product safety and quality.

Back to the Top

Preclinical Considerations in Cell and Gene Therapy Product Development
Detailed pharmacology/toxicology discussion on the preclinical considerations when evaluating and developing cell and gene therapy products, and principles of regulatory review.

Back to the Top

Clinical Study Issues in Early Phase Trials of Cell and Gene Therapies
Detailed discussion on the regulations related to early phase clinical trials of cell and gene therapies, including risks, protocol design, analysis, and donor issues.

Back to the Top

Office of Compliance and Biologics Quality

Inspections of CBER Regulated Products
Overview discussion on types of inspections, inspection teams, scope and coverage, and outcomes of an inspection.

Back to the Top

Compliance and Product Quality
Detailed discussion on regulatory actions, recalls and product deviation reports associated with inspections.

Back to the Top

CBER’s Bioresearch Monitoring Program: Clinical and Nonclinical Inspections
Overview of the Bioresearch Monitoring (BIMO) program at CBER, covering Good Clinical Practice and Good Laboratory Practice compliance as it relates to human protection, clinical trial data, and inspections.

Back to the Top

CBER’s Lot Release System: Overview of the Current Process
Detailed discussion of the receipt, processing and release of product lots via the lot release system, within the Division of Manufacturing and Product Quality, which includes review and testing.

Back to the Top

Office of Vaccines Research and Review

Overview of the Office of Vaccines Research and Review
Overview of the Office of Vaccines Research and Review, its organizational structure, laws and guidance, review of the regulated products, and OVRR’s research programs.

Back to the Top

Regulatory Perspective on Development of Preventive Vaccines for Global Infectious Diseases
Discussion on preventive vaccines for global infectious diseases, the regulatory pathway, epidemiological considerations, fast track programs, pediatric assessments, and safety monitoring.

Back to the Top

Pre-Licensure Review of Preventive Vaccines
Detailed discussion on the pre-licensure review of preventive vaccines, including pre-clinical and clinical evaluation, review process, and the manufacturing and characterization of vaccines.

Back to the Top

Regulatory Considerations in the Safety Assessment of Adjuvants and Adjuvanted Preventive Vaccines
Detailed discussion covering adjuvants and adjuvanted vaccines, definitions, product characteristics, Investigational New Drug (IND) requirements, and safety.

Back to the Top

Division of Product Quality
Discussion of the activities within the Division of Product Quality and its testing laboratories, as part of the Office of Compliance and Biologics Quality. Discussion includes quality systems, product testing, lot release, reference reagents and physical standards, and method validation.

Back to the Top

-

-