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, HFM-99, Suite 200N
1401 Rockville Pike Rockville, MD 20852-1448

Phone Number: 301-827-5102
Fax Number: 301-827-9796

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.