FDA Center for Biologics Evaluation and Research (CBER)
The Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration's (FDA) regulates a variety of products, and verifies or enforces requirements at the time the products are imported or offered for import into the US.
Getting Started with CBER
- Start Here! Introduction and Scope of the Office of Cellular, Tissue and Gene Therapies (OCTGT) Webinar Series
- Welcome to OTAT Learn
- Regulatory Advice Program:
INitial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) Meetings
- Development & Approval Process (CBER)
Products Regulated by CBER
Overview: CBER Regulated Products
- Biological products, including blood and blood products, vaccines, allergenics, gene therapies and xenotransplantation.
- Human cells and tissue products (HCT/Ps) that are intended for implantation, transplantation, infusion, or transfer into a human recipient. This may include bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.
- Medical devices involved in the collection, processing, testing, screening, manufacture and administration of blood, blood components, and human tissue and cellular products.
- HIV test kits used to screen donor blood, blood components and tissue and cellular products (HCT/Ps), and products used to diagnose, treat, and monitor persons with HIV and AIDS.
- Certain drug products, including blood bags with anti-coagulant.
Categories of Therapeutic Biological Products Remaining in CBER
Overview: Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER)
- Cellular products, including products composed of human, bacterial or animal cells (such as pancreatic islet cells for transplantation), or from physical parts of those cells (such as whole cells, cell fragments, or other components intended for use as preventative or therapeutic vaccines).
- Gene therapy products. Human gene therapy/gene transfer is the administration of nucleic acids, viruses, or genetically engineered microorganisms that mediate their effect by transcription and/or translation of the transferred genetic material, and/or by integrating into the host genome. Cells may be modified in these ways ex vivo for subsequent administration to the recipient, or altered in vivo by gene therapy products administered directly to the recipient.
- Vaccines (products intended to induce or increase an antigen specific immune response for prophylactic or therapeutic immunization, regardless of the composition or method of manufacture).
- Allergenic extracts used for the diagnosis and treatment of allergic diseases and allergen patch tests.
- Antitoxins, antivenins, and venoms
- Blood, blood components, plasma derived products (for example, albumin, immunoglobulins, clotting factors, fibrin sealants, proteinase inhibitors), including recombinant and transgenic versions of plasma derivatives, (for example clotting factors), blood substitutes, plasma volume expanders, human or animal polyclonal antibody preparations including radiolabeled or conjugated forms, and certain fibrinolytics such as plasma-derived plasmin, and red cell reagents.
Resources by Technology Category
The resources below are to connect entrepreneurs with a set of curated links available from the United States Food and Drug Administration (FDA) and contain links to resources that are relevant for early-stage companies developing oncology-related therapeutic products.
Orphan Drug/Rare Disease
I am working on an orphan drug/rare disease – where can I get started?
- Overview: Developing Products for Rare Diseases & Conditions
- Orphan Drug Designation Request Form and Related Webinar (drugs and biological products)
- Webinars on topics related to development of products intended to treat rare diseases
I am working on a drug/device combination or drug delivery product – where can I get started?
- Combination Products Contacts
- Request for Designation (RFD) Process to assign jurisdiction to for combination products
- Combination Products Guidance Documents
- Principles of Premarket Pathways for Combination Products
- Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
Regenerative Medicine Therapy
I am working on a regenerative medicine therapy – where can I get started?
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
- Evaluation of Devices Used with Regenerative Medicine Advanced Therapies
I am working on a cell-based therapy – where can I get started?
Premarket Submission Resources
What is the right premarket submission for my technology?
Biologic License Application (BLA) Resources
- Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products
- Clinical Considerations for Therapeutic Cancer Vaccines
- S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
- S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Expedited Review Programs
Investigational New Drug (IND) Resources