№ lp_1_2_06999
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This document is a sample letter template for medical necessity requests regarding VONVENDI® for patients with von Willebrand disease.
Year:
2025
Region / City:
United States
Theme:
Medical necessity letter
Document type:
Medical letter
Organization / Institution:
Takeda Pharmaceuticals U.S.A., Inc.
Author:
Takeda Pharmaceuticals U.S.A., Inc.
Target audience:
Physicians, insurance providers
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
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Year:
(not specified)
Region / city:
(not specified)
Topic:
Haematology, von Willebrand disease
Document type:
Audit report
Organization / institution:
British Society for Haematology
Author:
(not specified)
Target audience:
Healthcare professionals in haematology
Period of validity:
(not specified)
Approval date:
(not specified)
Date of changes:
(not specified)
Year:
2023
Region / city:
Australia
Topic:
Vaccination, Immunocompromised individuals, Herpes Zoster
Document type:
Government recommendation
Organization:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
PBAC
Target audience:
Healthcare professionals, Immunocompromised individuals
Period of validity:
From November 1, 2023
Approval date:
November 1, 2023
Modification date:
September 2023
Note:
Year
Subject:
Biosafety, Recombinant Nucleic Acids, Synthetic Nucleic Acids, Biohazardous Materials
Document Type:
Registration Form
Institution:
Stanley Manne Children’s Research Institute, Ann & Robert H. Lurie Children’s Hospital of Chicago
Target Audience:
Researchers conducting experiments involving recombinant or synthetic nucleic acids or biohazardous materials
Year:
2026
Region / City:
La Jolla, CA
Topic:
Gene Transfer, Viral Vectors
Document Type:
Request Form
Organization / Institution:
Salk Institute for Biological Studies
Author:
GT3 Core Facility
Target Audience:
Researchers, Investigators
Validity Period:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
Not specified
Region / City:
Not specified
Subject:
Biotechnology, Growth Factors
Document Type:
Product Information
Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, Laboratory Technicians
Validity Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Context:
Product information sheet for recombinant human fibroblast growth factor 2 (rhFGF2), detailing its properties, specifications, and uses in cell culture systems.
Year:
2023
Region / city:
Not specified
Topic:
Recombinant proteins, antibodies, and reagents for macrophage polarization and related techniques
Document type:
Laboratory protocol
Institution:
Not specified
Author:
Not specified
Target audience:
Researchers in molecular biology and immunology
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
Lexington, KY
Topic:
Recombinant DNA Technology, Molecular Genetics
Document Type:
Course Syllabus
Institution:
University of Kentucky
Instructor:
Dr. Brian Rymond
Target Audience:
Advanced Undergraduates, Graduate Students
Prerequisites:
Genetics, Cell Biology
Start Date:
Fall Semester
Approval Date:
N/A
Update Date:
N/A
Year:
2023
Region / city:
Belo Horizonte, Minas Gerais, Brazil
Topic:
Leprosy Diagnosis
Document Type:
Research Article
Institution:
Universidade Federal de Minas Gerais
Author:
Bárbara P.N. Assis, Ana T. Chaves, Daniela P. Lage, Mariana M. Cardoso, Isabela A.G. Pereira, Raquel S.B. Câmara, Camila S. Freitas, Fernanda Ludolf, Ana Laura G. de Oliveira, João A. Oliveira-da-Silva, Grasiele S.V. Tavares, Alexsandro S. Galdino, Miguel A. Chávez-Fumagalli, Ricardo A. Machado-de-Ávila, Myron Christodoulides, Denise U. Gonçalves, Lílian L. Bueno, Ricardo T. Fujiwara, Eduardo A.F. Coelho, Manoel Otávio da Costa Rocha
Target Audience:
Researchers, healthcare professionals, scientists in the field of infectious diseases and diagnostics
Period of Activity:
2023
Approval Date:
2023
Date of Changes:
N/A
Year:
2021
Region / Country:
United States
Subject:
Influenza vaccination
Document Type:
Vaccine Information Statement
Issuing Organization:
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention
Target Audience:
General public, children, pregnant individuals, older adults, people with chronic conditions
Vaccine Type:
Inactivated or Recombinant Influenza Vaccine
Administration Period:
Annual flu season (October–May)
Possible Reactions:
Soreness, redness, swelling, fever, muscle aches, headache, fainting, rare Guillain-Barré Syndrome
Reporting System:
Vaccine Adverse Event Reporting System (VAERS)
Compensation Program:
National Vaccine Injury Compensation Program (VICP)
Guidance Source:
FDA, CDC
Year:
2026
Organism:
Escherichia coli ER2566
Target genes:
HPV L1 from types 6, 11, 16, 18, 31, 33, 45, 52, 58
Techniques:
PCR, SDS-PAGE, western blotting, chromosomal integration, plasmid-based expression
Gene loci:
lpxM, lpxP, pagP, lpxL, eptA, kdsD, gutQ
Type of document:
Supplementary material for a research study
Experiment scale:
Shake-flask and large-scale fermentation
Analysis:
Protein expression, plasmid maintenance, growth curves, transcript levels
Focus:
Comparative evaluation of single-copy versus multi-copy gene integration
Organization:
Institutional Biosafety Committee (IBC), Ann & Robert H. Lurie Children’s Hospital of Chicago
Document Type:
Administrative Form
Purpose:
Inactivation of an approved biosafety research protocol after project completion
Subject Area:
Biosafety and Biohazardous Research Oversight
Related Activities:
Research involving recombinant and synthetic nucleic acid molecules and biohazardous materials
Submission Method:
E-mail submission to [email protected]
Responsible Role:
Principal Investigator (PI)
Compliance Reference:
NIH Guide for the shipment and transfer of recombinant and synthetic nucleic acids
Key Declarations:
Confirmation of project completion, biosafety compliance, disposal of biohazards, and proper storage of biological agents
Required Fields:
Date of report, biosafety registration number, protocol title, PI name, PI email, investigator signature, date
Approval Authority:
Institutional Biosafety Committee
Year:
1968–2011
Region / Institution:
Centers for Disease Control and Prevention, Atlanta, GA, USA
Topic:
Virology, Influenza virus research
Document type:
Supplementary tables and figures
Authors:
Hua Yang, Paul J. Carney, Jessie C. Chang, Zhu Guo, Julie M. Villanueva, James Stevens
Target audience:
Researchers in virology and immunology
Methodology:
Glycan array analysis of recombinant hemagglutinins
Data coverage:
Multiple A(H3N2) strains from 1968 to 2011
Experimental focus:
Receptor binding specificity and glycan interactions
Year:
2023
Region / City:
Harbin, China
Topic:
Immunology, Parasitology
Document Type:
Research Article
Organization / Institution:
College of Veterinary Medicine, Northeast Agricultural University
Authors:
Xuhong Yuan, Xuejiao Yang, Caixia Han
Target Audience:
Researchers in immunology and parasitology
Period of Action:
N/A
Date of Approval:
N/A
Date of Modifications:
N/A
Year:
2026
Institution:
National Institutes of Health (NIH)
Type of Document:
Guidance / Regulatory Summary
Subject:
Recombinant DNA (rDNA) and Synthetic DNA (sDNA) research
Author:
NIH Office of Biotechnology Activities (OBA)
Target Audience:
Researchers using NIH funds, Institutional Biosafety Committees
Scope:
United States, applicable to institutions receiving NIH funding
Regulatory References:
NIH Guidelines, CDC Select Agent Program, BMBL Manual
Compliance Requirements:
Institutional Biosafety Committee (IBC) approval, RAC review, IRB approval for human research, adherence to biosafety and waste management protocols
Publication Date:
2026
Website Reference:
http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines
Year:
2026
Institution:
Jiangnan University, National Engineering Laboratory of Cereal Fermentation Technology
Authors:
Manman SUN, Xiong GAO, Zihao ZHAO, An LI, Yali WANG, Yankun YANG, Xiuxia LIU, Zhonghu BAI
Document type:
Supplementary materials
Target audience:
Researchers in microbiology and biotechnology
Organism studied:
Corynebacterium glutamicum, Escherichia coli
Methodology:
Construction and testing of bicistronic gene expression vectors
Plasmids and strains:
Listed in tables S1–S3
Gene targets:
EGFP, ALDH, ADH, RamA, PNP, gD, BoIFN
Techniques:
PCR, qPCR, genetic cloning
Correspondence:
[email protected]; [email protected]