References for the Regulatory Process for the Office of Tissues and Advanced Therapies

Thank you for inquiring with the Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) regarding your proposed product. In preparation for future communications please see the following references which may address some of your initial questions, and give you a better understanding of the regulatory process. After reviewing this information please contact the OTAT Branch Chief, Regulatory Project Management Staff if you would like to set up a pre-Investigational New Drug application (IND) meeting.

OTAT organization, mailing address, and contact numbers:

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Tissues and Advanced Therapies
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

Phone Number: 240-402-8190

OTAT is comprised of 5 Divisions in addition to the Office of the Director:

• Division of Cellular and Gene Therapies (DCGT)
• Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT)
• Division of Human Tissues (DHT)
• Division of Plasma Protein Therapeutics (DPPT)
• Division of Regulatory Project Management (DRPM)

DCGT, DCEPT and DPPT constitute the main review disciplines of the regulatory review process: Product, Preclinical (pharmacology/toxicology), and Clinical.

Information about CBER

• About the Center for Biologics Evaluation and Research (CBER)
• FDA Organization Charts

Formal Communications & Meetings

• Formal Meetings Between the FDA and Sponsors or Applicants

Policies and Procedures

• Investigational New Drug Applications (INDs) for CBER-Regulated Products
• Biologics Procedures (SOPPs)
• Biologics Rules
• Biologics Guidances

Compliance and Enforcement

• Exporting CBER-Regulated Products
• Guidance, Compliance & Regulatory Information (Biologics)
• Enforcement Actions (CBER)
• Tissue Safety & Availability

Cellular & Gene Therapy

• Cellular & Gene Therapy Products
• Cellular & Gene Therapy Guidances
• CBER-CDRH Cross-Center Guidance Documents
• Cellular, Tissue, and Gene Therapies Advisory Committee

Tissue & Tissue Products

• Tissue & Tissue Products
• Tissue Guidances
• Tissue Notices, Proposed and Final Rules
• Cellular, Tissue, and Gene Therapies Advisory Committee
• Questions about Tissues

Xenotransplantation

• Xenotransplantation

OTAT Learn

OTAT Learn is a series of educational webinars specific to products regulated in the Office of Tissues and Advanced Therapies.

• OTAT Learn