№ lp_1_2_72215
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This document is a Regulatory Impact Statement addressing concerns over the adequacy of existing standards for human blood, blood components, tissues, and human cell therapy products in Australia, focusing on technological advancements and evolving industry needs.
Year:
2013
Region / City:
Australia
Subject:
Human cellular and tissue therapies (HCTs) regulation
Document Type:
Regulatory Impact Statement
Institution:
Therapeutic Goods Administration (TGA)
Author:
Office of Scientific Evaluation / Office of Manufacturing Quality
Target Audience:
Government, Healthcare professionals, Industry stakeholders
Effective Date:
January 2013
Period of Validity:
Ongoing revision of standards
Date of Approval:
January 2013
Date of Last Revision:
N/A
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Year:
2010
Region / City:
Grahamstown
Subject:
Biomaterials transfer, research agreements
Document Type:
Agreement
Organization / Institution:
South African Institute for Aquatic Biodiversity (SAIAB)
Author:
SAIAB Collections Manager
Target Audience:
Researchers, research institutions
Effective Period:
Not specified
Approval Date:
18 March 2010
Modification Date:
Not specified
Context:
Legal agreement for the transfer of biomaterials from SAIAB collections to researchers for research purposes.
Year:
2009
Subject:
Biology
Topic:
Plant structure and function
Educational standard:
Next Generation Sunshine State Standards
Benchmark code:
SC.912.L.14.7
Course level:
Biology 1
Document type:
Student instructional packet
Institution:
Office of Academics and Transformation
Academic focus:
Plant organs, tissues, and physiological processes
Target audience:
Secondary school students
Content components:
Tutorial activities, background reading, vocabulary, questions, tables
Source attribution:
Department of Biology, University of Pennsylvania
Curricular context:
Organisms, populations, and ecosystems
Year:
2004
Region / City:
USA
Topic:
Health regulations, Donor eligibility
Document type:
Regulatory guidance
Organization / Institution:
U.S. Department of Health and Human Services, Food and Drug Administration
Author:
U.S. Department of Health and Human Services, Food and Drug Administration
Target audience:
Healthcare professionals, tissue product manufacturers
Period of validity:
N/A
Approval date:
May 25, 2004
Date of changes:
N/A
Context:
Regulatory guidelines and FDA documentation related to the eligibility criteria for donors of human cells, tissues, and cellular products.
Year:
2019-2020
Region / City:
Shanghai, China
Field:
Medical research, oncology
Document type:
Research article
Institution:
Zhongshan Hospital Fudan University
Authors:
Not specified
Target audience:
Researchers, medical professionals
Study period:
May 2019 - February 2020
Approval date:
B2019-060R
Follow-up end date:
March 31, 2020
Year:
2017
Region / City:
Netherlands, Canada
Topic:
DNA Methylation Analysis
Document Type:
Research Supplementary Materials
Institution:
Not specified
Author:
Forest et al.
Target Audience:
Researchers in genomics and molecular biology
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Note:
Year
Theme:
Plant biology
Document type:
Educational material
Target audience:
Students, researchers
Procedure Code:
CPT 51715
Procedure Name:
Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck
Clinical Indication:
Stress urinary incontinence in women
Population:
Women with stress urinary incontinence
Evidence Sources:
Cochrane Review (Kirchin 2012); NICE 2005; NICE 2019; American Urology Association 2017; Syan 2016; MODA 2019; Aetna 2019
Study Types Referenced:
Randomized controlled trials; case series; systematic review; guideline statements
Comparators:
Conservative treatment; placebo injection; surgical management; pelvic floor muscle training
Reported Outcomes:
Continence rates; quality of life; patient satisfaction; adverse events; objective cure
Adverse Events Reported:
Urinary tract infection; urinary retention; dysuria; abscess; urgency of micturition; prolonged pain; haemorrhage; migration of bulking agent; allergic reaction
Regulatory Reference:
FDA-cleared bulking agents listed (Coaptite, Contigen, Durasphere, Macroplastique, Uryx)
Coverage Criteria:
Prior conservative management; defined duration of symptoms; documented improvement after initial treatments; limitation on number of injections
Guideline Recommendations:
Consider in patients unsuitable for or declining surgery; counseling on limited long-term efficacy and potential need for repeat injections
Review Date Mentioned:
August 2019
Title:
Million Match Teach-In 1: What Is Hyp? Connective Tissues and Care Access
Date:
December 9, 2024
Campaign Period:
December 2024 through May 2025
Organization:
Hyp+Access
Program:
Hyp+Care
Event Format:
Live virtual teach-in (Zoom) with asynchronous YouTube access
Type of Document:
Event transcript / educational presentation transcript
Speakers:
L Tuthall; Audre Wirtanen
Roles:
Directors of Hyp+Access
Topic:
Hyp; connective tissue variance; care access
Audience:
Community members, patients, families, practitioners
Accessibility Features:
Auto captions; visual descriptions; chat moderation; captioned recording; published sources
Website:
hypaccess.org
Launch Context:
Opening event of the Million Match campaign
Year:
2004–2018
Country:
United States
Subject:
Donor eligibility and screening requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Document Type:
Reference list
Issuing Authority:
U.S. Department of Health and Human Services; Food and Drug Administration; Centers for Disease Control and Prevention; AABB; FACT/JACIE
Legal Framework:
21 CFR 1271, Subpart C – Donor Eligibility
Referenced Publications:
Final Rule (69 FR 29785, May 25, 2004); FDA Guidance for Industry documents (August 2007; November 2016; May 2017; May 2018); CDC Yellow Book; AABB Standards for Cellular Therapy Product Services; FACT/JACIE International Standards
Target Audience:
Industry stakeholders involved in donor screening and cellular therapy product services
Related Topics:
Zika virus; West Nile virus; Hepatitis B virus; human-derived clotting factor concentrates; malaria
Book Title:
Memmler’s Structure and Function of the Human Body
Edition:
11th Edition
Unit:
Unit I: The Body as a Whole
Chapter:
Chapter 4
Chapter Title:
Tissues, Glands, and Membranes
Page References:
pp. 64–75
Subject Area:
Human Anatomy and Physiology
Topics Covered:
Tissue origins; epithelial, connective, muscle, and nervous tissues; glands and secretions; membranes; tissue and aging
Document Type:
Chapter notes outline
Intended Audience:
Students of anatomy and physiology
Year:
2023
Organism:
Mus musculus
Tissue types:
Optic nerve, cerebellum, C2C12 cells
Techniques:
Cell lysis, transfection, RNA extraction, western blotting, immunofluorescence, RT-PCR
Reagents and tools:
RSB-100 buffer, TriZOL, Turbo DNase, Lipofectamine2000, plasmids (pcDNA3.1, tdTomato, Qk reporters), siRNAs, morpholinos, primary and secondary antibodies
Institution:
University of California, Santa Cruz
Animal model:
Adult wild-type 129-C57BL/6 mice
Ethics approval:
UCSC Institutional Animal Care and Use Committee
Target proteins:
QKI isoforms (QKI-5, QKI-6, QKI-7), GAPDH, Myc, HA, histone H3, tdTomato
Assays:
Dual Glo Luciferase Assay, BioAnalyzer quantitation, RT-qPCR
Method type:
Experimental protocol
Supplementary information:
Details on plasmid construction, antibody sources, and subcellular fractionation
Document Type:
Supplemental figure legends
Field:
Molecular biology
Research Area:
Gastrointestinal epithelium and intestinal metaplasia
Subjects:
CDX2, HNF4A, SOX2, gastric organoids, Barrett’s esophagus, gastric intestinal metaplasia
Biological Material:
Human gastrointestinal tissues and mouse stomach organoids
Methods:
Single-cell RNA-seq, bulk RNA-seq, ATAC-seq, CUT&RUN, ChIP-seq, GSEA, enhancer analysis, immunohistochemistry, qRT-PCR
Referenced Studies:
Busslinger et al. 2021b; Nowicki-Osuch et al. 2021; Owen et al. 2018; Companioni et al. 2017; Singh et al. 2021; Gao and Kaestner 2010; Wang et al. 2013
Key Topics:
Transcriptional profiling, chromatin accessibility, enhancer activity, transcription factor binding, intestinalization of gastric epithelium
Species:
Homo sapiens; Mus musculus
Pathological Context:
Barrett’s esophagus; gastric intestinal metaplasia
Document type:
Ethics self-assessment form
Subject area:
Research ethics
Context:
EU grant application process
Programme / initiative:
INNOVISION Postdoctoral COFUND
Responsible framework:
European Union research funding procedures
Primary topics:
Human embryonic stem cells, human embryos, human participants, human cells and tissues
Regulatory reference:
Clinical Trial Regulation 536/2014
Required documentation:
Ethics approvals, informed consent forms, information sheets, registry confirmations
Geographical scope:
European Union
Relevant registry:
European registry for human embryonic stem cell lines (hPSCreg)
Purpose within process:
Ethics compliance verification in research proposals
Year:
2026
Region / City:
Not specified
Topic:
Small Cell Lung Cancer, Gene Expression
Document Type:
Supplementary Figure / Research Data
Institution:
GTEx, Amgen
Methodology:
RNA-Seq, Immunohistochemistry, Flow Cytometry
Sample Size:
28 SCLC tumor samples, 3,789 GTEx normal tissue samples, 518 Amgen normal tissue samples
Markers:
DLL3
Data Visualization:
Log2 FPKM + 0.1, Photomicrographs
Experimental Details:
Secondary antibody controls included
Year:
2023
Region / City:
Not specified
Topic:
Oncology, Tumor Biomarkers
Document Type:
Research Supplementary Material
Institution:
Not specified
Author:
Not specified
Patient Cohort:
Bladder cancer patients
Sample Type:
Tumor tissues and organoids
Methodology:
Gene expression analysis using R software, Wilcoxon Rank Sum and Signed Rank Tests
Tumor Types:
GBM, GBMLGG, LGG, UCEC, BRCA, LUAD, ESCA, STES, KIRP, KIPAN, COAD, COADREAD, PRAD, STAD, HNSC, KIRC, LUSC, LIHC, WT, SKCM, BLCA, THCA, READ, OV, PAAD, TGCT, UCS, LAML, ACC, KICH, CHOL
Clinical Data Included:
Patient sex, age, pathological classification, prior therapy, organoid culture status
Figures:
Supplementary Figures S1, S2
Tables:
Supplementary Table 1
Year:
2023
Region / City:
Not specified
Subject:
Importing BMC-Compuware License File in ECC
Document Type:
Technical Guide
Organization:
BMC Software
Author:
Not specified
Target Audience:
IT professionals managing enterprise systems
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
Wisconsin
Theme:
Field welding, inspection, and procedures for pile splices and field welded components
Document Type:
Checklist
Organization / Institution:
Wisconsin Department of Transportation (DOT)
Author:
Bill Hardy, CWI; Ryan Janssen, CWI
Target Audience:
Contractors, engineers, and welding inspectors
Effective Period:
Current year
Approval Date:
N/A
Modification Date:
N/A
Year:
2025
Region / City:
Grand Haven, MI, USA
Subject:
Supplier Standards for Materials and Components
Document Type:
Supplier Manual
Organization:
Shape Corp.
Author:
Shape Corp.
Target Audience:
Materials and components suppliers to Shape Corp.
Period of Validity:
Ongoing
Approval Date:
June 1, 2025
Revision Date:
June 1, 2025
Year:
2026
Region / city:
N/A
Theme:
Disinformation, Truth Literacy, Political Literacy
Document Type:
Questionnaire
Author:
N/A
Target Audience:
Researchers, Educators, Political Scientists
Period of validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2025
Region / city:
Noordwijk, The Netherlands
Topic:
Radiation hardness assurance for EEE components
Document type:
Standard
Organization / institution:
European Space Agency (ESA), ECSS Secretariat
Author:
Radiation Hardness Assurance Working Group
Target audience:
Space industry professionals, engineers, and project managers in space missions
Effective period:
Ongoing
Approval date:
1 October 2012
Amendment date:
20 March 2025