Vaccines, Blood & Biologics

References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies

Thank you for inquiring with the Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies (OCTGT) 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 OCTGT Branch Chief, Regulatory Management Staff if you would like to set up a pre-Investigational New Drug application (IND) meeting.

OCTGT organization, mailing address, and contact numbers:

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

Phone Number: 240-402-8190

OCTGT is comprised of 3 Divisions in addition to the Office of the Director which includes the Regulatory Management Staff (RMS):

  • Division of Cellular and Gene Therapies (DCGT)
  • Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT)
  • Division of Human Tissues (DHT)

These Divisions constitute the 3 main review disciplines of the regulatory process: Product, Preclinical (pharmacology/toxicology), and Clinical.

Xenotransplantation

OCTGT Learn

OCTGT Learn is a series of educational webinars specific to products regulated in the Office of Cellular, Tissues and Gene Therapies

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/03/2015
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