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                Cellular & Gene Therapy Products

Cellular & Gene Therapy Products

                        Approved Cellular and Gene Therapy Products Home
          Vaccines, Blood & Biologics
          Cellular & Gene Therapy Products
          Establishment of the Office of Therapeutic ProductsCellular & Gene Therapy Products Establishment of the Office of Therapeutic Products
  
  	
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    PrintThe mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER is making changes to its organizational structure in order to address the substantial growth in the development of innovative, novel products and the ever-changing public health landscape.

In order to meet these challenges head on, CBER has established the new Office of Therapeutic Products (OTP). This new super office is the result of a reorganization of the Center’s Office of Tissues and Advanced Therapies and includes six new offices within the super office structure. This reorganization creates flexibility and capacity for future growth in the number of Full-Time Employee (FTE) positions as CBER works to meet the commitments and hiring goals outlined in the Prescription Drug User Fee Agreement (PDUFA) for fiscal years 2023-2027. The structural changes improve discipline alignment, increase review capacity, and enhance expertise in cell and gene therapies. Additional review staff and supervisory positions will not only help to address the increased workload but will also enhance the timeliness and consistency of the office’s interactions with sponsors and provide advancement opportunities to facilitate recruitment and retention of highly qualified staff.

OTP Organizational Structure
	OTP is comprised of 6 Offices overseeing 14 Divisions and 33 Branches as listed in the high-level view of the super office structure below.

Office of Gene Therapy Chemistry, Manufacturing and Controls (CMC)
	Division of Gene Therapy 1
		Gene Therapy Branch 1
			Gene Therapy Branch 2
			Gene Therapy Branch 3
		Division of Gene Therapy 2
		Gene Therapy Branch 4
			Gene Therapy Branch 5
			Gene Transfer and Immunogenicity Branch
	Office of Cellular Therapy and Human Tissue CMC 
	Division of Cell Therapy 1
		Cell Therapy Branch 1
			Cell Therapy Branch 2
			Cellular and Tissue Therapy Branch
		Division of Cell Therapy 2
		Tissue Engineering Branch 1
			Tissue Engineering Branch 2
			Tumor Vaccine and Biotechnology Branch
		Division of Human Tissues
		Human Tissue/Reproduction Branch
	Office of Plasma Protein Therapeutics CMC
	Division of Hemostasis
		Hemostasis Branch 1
			Hemostasis Branch 2
		Division of Plasma Derivatives
		Plasma Derivatives Branch 1
			Plasma Derivatives Branch 2
	Office of Clinical Evaluation
	Division of General Medicine
		General Medicine Branch 1
			General Medicine Branch 2
			General Medicine Branch 3
			General Medicine Branch 4
		Division of Oncology
		Oncology Branch 1
			Oncology Branch 2
		Division of Hematology
		Benign Hematology Branch
			Malignant Hematology Branch
	Office of Pharmacology/Toxicology
	Division of Pharmacology/Toxicology 1
		Pharmacology/Toxicology Branch 1
			Pharmacology/Toxicology Branch 3
		Division of Pharmacology/Toxicology 2 
		Pharmacology/Toxicology Branch 2
			Pharmacology/Toxicology Branch 4
	Office of Review Management and Regulatory Review
	Division of Review Management and Regulatory Review 1
		Regulatory Project Management (RPM) Branch 1
			RPM Branch 3
		Division of Review Management and Regulatory Review 2
		RPM Branch 2
			RPM Branch 4

OTP Organization Question and Answers
	**What is the structure of the new OTP?**

	The Office of Tissues and Advanced Therapies (OTAT) was reorganized to become the Office of Therapeutic Products (OTP) and transitioned into a super office structure. New offices created within the super office structure align disciplines and product types, allowing our workforce to address the exponential growth in cell and gene therapies. This updated structure will enable OTP to:
		Provide oversight and coordination across programs
			Ensure flexibility for current and future growth in staff
			Distribute workload more evenly
			Support industry needs and commitments
			Enhance expertise in highly specialized disciplines
		Within OTP, six (6) Offices have been established:
		Office of Gene Therapy Chemistry, Manufacturing, and Controls (CMC)
			Office of Cellular Therapy and Human Tissue CMC
			Office of Plasma Protein Therapeutics CMC
			Office of Clinical Evaluation
			Office of Pharmacology/ Toxicology
			Office of Review Management and Regulatory Review
	**How is hiring being addressed in relation to implementation of the new super office?**
	The new super office is scheduled to be implemented on February 26, 2023. The Center is actively working to fill new leadership positions created through the establishment of the new super office structure. While permanent selections are being finalized, individuals will be identified for acting positions. The Center continues to fill vacancies across the office to ensure adequate staffing to address the workload.
	**How will this affect processes and communications with sponsors?**
	A goal of the reorganization process is to enhance the timeliness and consistency of communication with sponsors. This webpage provides sponsors with information on the organization.
	**How do the new structural changes impact current processes and communications between sponsors and FDA?**
	The first point of contact will remain the regulatory project manager (RPM) previously assigned to a submission and each letter a sponsor receives will continue to identify that point of contact. CBER will update its website to reflect the new organizational leadership and provide additional contact information.
		Submissions will be routed within OTP to ensure they are sent to the appropriate office in the new structure.
	**Will BLA or IND applications that were under review in OTAT prior to the reorganization be affected? Will the processing of these applications take longer because of these changes?**
	OTP’s goal is to maintain review teams for existing applications throughout the reorganization. However, the responsible offices and divisions, as well as the signatory authority responsible for existing applications, may change – this will be determined by several factors, including how far along the review of the application is at the time of the reorganization.
		OTP is committed to meeting all statutory commitments.
	**Will there be changes to CBER’s Standard Operating Policies and Procedures (SOPPs) as well as guidance documents related to INDs and marketing applications?**
	CBER SOPPs and guidance documents related to INDs and marketing applications may be updated as a result of the reorganization to reflect new organizational titles and processes. CBER and OTP have a team dedicated to administrative activities. Consistent with our good guidance practices, we welcome comments on our guidance documents. Updated documents and policies and procedures will be posted on the FDA website.
	**Where should interested parties go for more information?**
	We will continue to post information and updates about the organization on the CBER webpage. If you have specific questions, please reach out to industry.biologics@fda.hhs.gov.

                                                                                  Content current as of:
      03/15/2023Cellular & Gene Therapy Products

          
                        Approved Cellular and Gene Therapy Products
 
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