Cellular, Tissue, and Gene Therapies Advisory Committee
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) is a component of the U.S. Food and Drug Administration (FDA), located in Silver Spring, Maryland. It advises on the regulation of products involving human cells, tissues, and gene therapies, ensuring they are safe and effective for clinical use.
Mission
The mission of CTGTAC is to provide scientific and medical advice to the FDA concerning the regulation of cellular, tissue, and gene therapies. This includes the evaluation of clinical trials, product safety, efficacy, and potential risks associated with these innovative treatments.[1]
Parent organization
CTGTAC is part of the Food and Drug Administration (FDA), which falls under the Department of Health and Human Services. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
Legislation
While not established by a specific piece of legislation, CTGTAC operates under the broader regulatory framework provided by the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, which govern the regulation of biological products and medical treatments.
Partners
- Biotechnology and pharmaceutical companies for product review
- Academic and research institutions for scientific collaboration
- Other FDA advisory committees for interdisciplinary advice
Number of employees
The committee does not have permanent employees but consists of voting members, including experts in cellular biology, immunology, genetics, and related fields.
Organization structure
CTGTAC's structure includes:
Leader
The committee's proceedings are managed by the Designated Federal Officer (DFO).
Divisions
- Operates as a single committee with members appointed for their specialized knowledge.
List of programs
- Review of new biologics license applications (BLA) for cellular and gene therapies
- Discussions on regulatory science related to these therapies
- Public meetings to discuss significant issues like safety protocols or clinical trial designs[2]
Last total enacted budget
Specific budget information for CTGTAC is not publicly disclosed, as it is part of the FDA's broader advisory committee operations.
Staff
Staffing for meetings includes the DFO and support from FDA staff; the committee members serve in an advisory capacity.
Funding
Funding for CTGTAC activities is part of the FDA's overall budget for advisory committee operations.
Services provided
CTGTAC provides recommendations on the approval, labeling, and post-marketing surveillance of cellular, tissue, and gene therapies. It evaluates the ethical, scientific, and regulatory aspects of these treatments to ensure they meet safety and efficacy standards.[3]
Headquarters address
10903 New Hampshire Ave, Silver Spring, MD 20993
History
CTGTAC was established to address the growing field of cellular and gene therapies, with its charter regularly renewed to keep pace with scientific advancements and regulatory needs. It has played a key role in the development and oversight of some of the most innovative treatments in medicine.
External links
References
- ↑ Food and Drug Administration (2025). "Cellular, Tissue, and Gene Therapies Advisory Committee". FDA.
- ↑ Food and Drug Administration (2025). "Cellular, Tissue, and Gene Therapies Advisory Committee Meetings". FDA.
- ↑ Food and Drug Administration (2025). "Cellular, Tissue, and Gene Therapies Advisory Committee Meetings". FDA.