№ lp_1_2_61689
File format: docx
Character count: 3801
File size: 31 KB
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.
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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:
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
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:
2016
Region / City:
United States
Topic:
Electronic Informed Consent (eIC)
Document Type:
Guidance
Agency / Institution:
Office for Human Research Protection (OHRP), Food and Drug Administration (FDA)
Author:
Office for Human Research Protection (OHRP), FDA
Target Audience:
Researchers, IRBs, Clinical Investigators, and Study Participants
Period of Validity:
Ongoing
Approval Date:
December 2016
Date of Revisions:
Not specified
Year:
2013–2019
Region:
United States
Subject:
Medical device regulatory submissions
Document type:
Regulatory guidance
Program:
FDA Q-Submission (Q-Sub) Program
Regulatory authority:
U.S. Food and Drug Administration
Centers:
Center for Devices and Radiological Health; Center for Biologics Evaluation and Research
Submission types covered:
Pre-Submission; Submission Issue Request; Study Risk Determination; Informational Meeting
Format requirements:
eCopy
Effective requirement date for eCopy:
January 1, 2013
Final rule date for electronic submissions:
December 13, 2019
Intended audience:
Medical device sponsors and applicants
Scope:
Premarket submissions including IDE, 510(k), PMA, HDE, and De Novo requests
Administrative timeline:
15 calendar days acceptance review; meeting scheduling prior to day 75
Year:
2005
Issuing Organization:
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Division of Immunology and Hematology Devices
Document Type:
Guidance Document
Target Audience:
Industry and FDA Staff
Subject:
AFP-L3% Immunological Test Systems, In Vitro Diagnostic Devices, Class II Special Controls
Date Issued:
October 4, 2005
Contact:
Donna Roscoe, [email protected]
Note:
, 301-796-6183
Year:
2023
Region / City:
Duke University
Theme:
Medical Device Regulation
Document Type:
Instructional Document
Organization / Institution:
Duke Office of Regulatory Affairs and Quality
Author:
Duke University
Target Audience:
Medical device developers, regulatory affairs professionals
Period of validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.