VRBPAC or CTGTAC?

Comparison of FDA advisory committees VRBPAC and CTGTAC

VRBPAC (Vaccines and Related Biologics)REPORTS TO: FDA
CTGTAC (Cellular Tissue and Gene Therapy)REPORTS TO: FDA
VRBPAC (Vaccines and Related Biologics)SUPPORT SERVICES: Center for Biologics Evaluation and Research (CBER)
CTGTAC (Cellular Tissue and Gene Therapy)SUPPORT SERVICES: Center for Biologics Evaluation and Research (CBER)
VRBPAC (Vaccines and Related Biologics)SCOPE: “The Vaccines and Related Biological Products Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective vaccines and related biological products for human use and as required, any other product for which the Food and Drug Administration (FDA) has regulatory responsibility.” [Emphasis added.]
CTGTAC (Cellular Tissue and Gene Therapy)SCOPE: “The Cellular, Tissue, and Gene Therapies Advisory Committee advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration (FDA) has regulatory responsibility.”
VRBPAC (Vaccines and Related Biologics)DUTIES: “The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.” [Emphasis added.] [https://www.fda.gov/advisory-committees/committees-and-meeting-materials]
CTGTAC (Cellular Tissue and Gene Therapy)DUTIES: “The Committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.” [Emphasis added.] [https://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/charter-cellular-tissue-and-gene-therapies-advisory-committee]
VRBPAC (Vaccines and Related Biologics)AUTHORITY: “The Vaccines and Related Biological Products Advisory Committee (the Committee) was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14, 330.10(a); is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2)”
CTGTAC (Cellular Tissue and Gene Therapy)AUTHORITY: “The Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee ) was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14, 330.10(a); and is governed by Pub. L. 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2).”
VRBPAC (Vaccines and Related Biologics)Estimated Annual Operating COST:
CTGTAC (Cellular Tissue and Gene Therapy)Estimated Annual Operating COST:
VRBPAC (Vaccines and Related Biologics)$522,882 for compensation and travel expenses + estimated staff costs $378,164 = $901,046
CTGTAC (Cellular Tissue and Gene Therapy)$287,211 for compensation and travel expenses + estimated staff costs $355,573 = $642,784
Table with 2 columns and 7 rows.
REPORTS TO: FDAREPORTS TO: FDA
SUPPORT SERVICES: Center for Biologics Evaluation and Research (CBER)SUPPORT SERVICES: Center for Biologics Evaluation and Research (CBER)
SCOPE: “The Vaccines and Related Biological Products Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective vaccines and related biological products for human use and as required, any other product for which the Food and Drug Administration (FDA) has regulatory responsibility.” [Emphasis added.]SCOPE: “The Cellular, Tissue, and Gene Therapies Advisory Committee advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration (FDA) has regulatory responsibility.”
DUTIES: “The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.” [Emphasis added.] [https://www.fda.gov/advisory-committees/committees-and-meeting-materials]DUTIES: “The Committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.” [Emphasis added.] [https://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/charter-cellular-tissue-and-gene-therapies-advisory-committee]
AUTHORITY: “The Vaccines and Related Biological Products Advisory Committee (the Committee) was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14, 330.10(a); is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2)”AUTHORITY: “The Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee ) was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14, 330.10(a); and is governed by Pub. L. 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2).”
Estimated Annual Operating COST:Estimated Annual Operating COST:
$522,882 for compensation and travel expenses + estimated staff costs $378,164 = $901,046$287,211 for compensation and travel expenses + estimated staff costs $355,573 = $642,784
Table: Lora Hammill, BSMT, ASCP; Loree Britt; Michelle Cibelli, RN, BSN; Erika Delph, RPh; Chris Flowers, MD; Barbara Gehrett, MD; Joseph Gehrett, MD; Cassie Papillion; David Shaw; and Tony DamianSource: DailyCloutGet the dataCreated with Datawrapper