- Cellular, Tissue, and Gene Therapies AdComm
Meeting Date: 4/15/21-4/15/21
The Committee will meet in open session to discuss biologics license application (BLA) 125734 for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans). The applicant, CellTrans, Inc., has requested an indication for the “treatment of brittle Type 1 diabetes mellitus (T1D).” The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
|Location:||Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.||Related News Links:||Not Available|
- Cellular, Tissue and Gene Therapies Advisory Committee
Meeting Date: 5/8/20-5/8/20
On May 8, 2020, the committee will meet by teleconference. In open session, the committee will hear an overview and updates of research programs in the Tumor Vaccines and Biotechnology Branch (TVBB) and Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), CBER, FDA.
|Location:||VIRTUAL||Related News Links:||Not Available|
- Cellular, Tissue and Gene Therapies AdComm
Meeting Date: 10/12/17-10/12/17
On October 12, 2017, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Biologics License Application (BLA) 125610, voretigene neparvovec, submitted by Spark Therapeutics, Inc. The proposed indication (use) for this product is treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
|Location:||FDA Meeting Room||Related News Links:||Not Available|
- Cellular, Tissue, and Gene Therapies Advisory Committee
Meeting Date: 7/26/16-7/26/16
On July 26, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Molecular Oncology and the Laboratory of Biological Chemistry, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, FDA.
|Location:||FDA White Oak||Related News Links:||Not Available|