№ lp_1_21337
File format: docx
Character count: 26948
File size: 39 KB
Guidance document detailing the classification, special control requirements, and premarket submission considerations for AFP-L3% immunological test systems used in vitro for assessing risk of hepatocellular carcinoma.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Study type:
Supplementary material
Cohort size:
93 patients
Disease:
Metastatic melanoma
Methods:
Multiplex immunofluorescence, image cytometry, Cox regression, LASSO analysis
Data type:
Tables and figures
Variables analyzed:
Clinicopathologic characteristics, cell density, proximity measurements, immune biomarkers
Statistical software:
R
Target population:
Patients with metastatic melanoma
Follow-up period:
5 years
Journal:
World Journal of Gastrointestinal Endoscopy
Manuscript Number:
39904
Manuscript Type:
Minireview
Authors:
Ivana Plavsic; Ivana Zitinic; Ivana Mikolasevic; Goran Poropat; Goran Hauser
Affiliations:
Clinical Hospital Centre Rijeka; Medical Faculty University of Rijeka; Faculty of Health Studies University of Rijeka
Corresponding Author:
Goran Hauser, MD, PhD
Country:
Croatia
Received:
May 18, 2018
Accepted:
August 1, 2018
Publication Year:
2018
License:
Creative Commons Attribution Non Commercial (CC BY-NC 4.0)
Peer Review:
Fully peer-reviewed
Keywords:
Acute pancreatitis; Endoscopic retrograde cholangiopancreatography; Post-ERCP pancreatitis
Subject Area:
Gastroenterology; Pancreatic diseases; Endoscopic complications
Article Type:
Invited review article
Language:
English
Year:
2023
Region / city:
Mannheim, Germany
Topic:
Immunology, Pediatric Surgery
Document Type:
Review
Organization / Institution:
University Medical Center Mannheim, University Heidelberg
Author:
Laura Blum, Deirdre Vincent M.D., Michael Boettcher M.D. Ph.D., Jasmin Knopf Ph.D.
Target Audience:
Researchers, Medical Professionals
Period of Action:
2005–2023
Date of Approval:
Not provided
Date of Changes:
Not provided
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:
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.
Note:
Year
Topic:
Health, Pharmaceuticals
Document Type:
Informational Resource
Organization / Institution:
U.S. Food and Drug Administration
Target Audience:
Consumers, Healthcare Providers, Information Professionals, Researchers
Year:
2025
Region / city:
Massachusetts
Subject:
Tobacco product sales regulations
Document type:
Guidance Document
Organization / institution:
Massachusetts Association of Health Boards
Author:
Cheryl Sbarra, Esq., Executive Director and Senior Staff Attorney, Massachusetts Association of Health Boards; Christohper Banthin, Esq., Program Manager, Public Health Advocacy Institute; Lisa Stevens-Goodnight, Esq., Tobacco Control Director, Massachusetts Municipal Association; Sarah McColgan, Tobacco Control Director, Massachusetts Health Officers Association
Target audience:
Tobacco retailers and permit applicants
Effective period:
2025
Approval date:
12.30.25
Date of changes:
N/A
Year:
2021
Region / city:
United States
Topic:
Drug and Biologic Submission Forms
Document Type:
Regulatory Document
Organization:
U.S. Food and Drug Administration (FDA)
Author:
Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER)
Target Audience:
Pharmaceutical industry professionals, regulatory submission staff
Effective Period:
2021 and onwards
Approval Date:
Not specified
Modification Date:
Not specified
Date:
December 1, 2025 - January 27, 2026
Region / city:
USA
Topic:
Research oversight, FDA guidance updates
Document type:
Regulatory update
Institution:
FDA
Target audience:
Research professionals, oversight committees, investigators, research organizations
Period of validity:
December 1, 2025 - January 27, 2026
Approval date:
December 1, 2025
Modification date:
January 27, 2026
Year:
2018
Jurisdiction:
Rwanda
Document type:
Regulation
Governing body:
Rwanda Food and Drugs Authority (Rwanda FDA)
Approval date:
09/02/2018
Revision date:
11/08/2025
Version:
1
Scope:
Processed food products and related items
Articles:
64
Chapters:
7
Regulated activities:
Manufacturing, licensing, inspection, import/export, registration, promotion, advertisement
Applicable standards:
GMP, GSP, GDP
Year:
Not specified
Region / City:
Not specified
Topic:
Clinical research documentation
Document type:
Standard Operating Procedure
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Study Investigators, Study Coordinators, Regulatory Affairs, Sponsors
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2002
Region / City:
USA
Topic:
Medical Device Regulation
Document Type:
Guidance
Organization / Institution:
U.S. Department of Health and Human Services, Food and Drug Administration
Author:
FDA
Target Audience:
Industry, Device Manufacturers
Period of Validity:
Not specified
Approval Date:
April 30, 2002
Date of Changes:
Not specified
Year:
2023
Region / city:
United States
Topic:
Clinical research, FDA IND/IDE, Regulatory compliance
Document type:
Checklist
Organization / institution:
National Institute of Mental Health (NIMH)
Author:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
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:
2015
Region / City:
USA
Subject:
Clinical research, FDA inspection
Document Type:
Standard Operating Procedure (SOP)
Author:
Principal Investigator, FDA
Target Audience:
Clinical research personnel
Period of Validity:
N/A
Approval Date:
01/01/2015
Effective Date:
01/01/2015
Review/Revision Date:
06/01/2016
Year:
2025
Region / City:
Haifa, Israel
Topic:
Quality Management System Regulation (QMSR)
Document Type:
Training Overview
Organization:
Not specified
Author:
Dr. Sivan Luder
Target Audience:
Professionals in the medical device industry (Quality, Regulatory, R&D, Manufacturing, Engineering, Clinical teams)
Effective Period:
Until 2026
Approval Date:
Not specified
Modification Date:
Not specified
Context:
Training document on the new U.S. FDA QMSR regulation, aimed at helping professionals in the medical device industry prepare for its full implementation.