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                Other Recommendations for Biologics Manufacturers

Other Recommendations for Biologics Manufacturers Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Other Recommendations for Biologics Manufacturers
          References for the Regulatory Process for the Office of Tissues and Advanced TherapiesOther Recommendations for Biologics Manufacturers References for the Regulatory Process for the Office of Tissues and Advanced Therapies
  
  	
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    PrintThank 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 ChartsFormal Communications & Meetings

Formal Meetings Between the FDA and Sponsors or ApplicantsPolicies and Procedures

Investigational New Drug Applications (INDs) for CBER-Regulated Products
	Biologics Procedures (SOPPs)
	Biologics Rules
	Biologics GuidancesCompliance and Enforcement

Exporting CBER-Regulated Products
	Guidance, Compliance & Regulatory Information (Biologics)
	Enforcement Actions (CBER)
	Tissue Safety & AvailabilityCellular & Gene Therapy

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

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

XenotransplantationOTAT Learn

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

OTAT Learn

                                                                                  Content current as of:
      03/23/2018
              
              
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  Gene TherapyTopic(s)
			  Application & ApprovalsOther Recommendations for Biologics Manufacturers
 
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