№ files_lp_4_process_1_39495
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This worksheet provides criteria and guidelines for compassionate use of an unapproved medical device and includes sections for informed consent and institutional approvals.
Year:
2025
Region / City:
N/A
Topic:
Medical Device, Compassionate Use
Document Type:
Worksheet
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Investigators, Designated Reviewers
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
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Note:
Year
Subject:
Emergency Use Treatment
Document Type:
Informed Consent Form
Note:
Year
Type of Document:
Informed Consent Form
Target Audience:
Patient or legal representative
Treatment:
Unapproved drug, device, or biologic
Condition:
Serious medical condition without FDA-approved treatments
Duration of Treatment:
Specified per case
Risks:
Potential unknown harms including death or harm to fetus
Costs:
May be billed to patient or insurance
Oversight:
Institutional Review Board (IRB) and FDA
Year:
2026
Country:
Australia
Type of document:
Application form
Issuing authority:
Therapeutic Goods Administration (TGA)
Intended audience:
Medical practitioners
Purpose:
Application to become an authorised prescriber of unapproved medicines or medical devices
Regulatory reference:
Therapeutic Goods Regulations 1990, Regulation 12B(1B)
Required attachments:
Ethics committee or specialist college approval/declaration (if applicable)
Information collected:
Personal details of medical practitioner, patient consent, product information, prescribing details
Submission method:
Email or fax to TGA
Year:
2026
Region / City:
United States
Theme:
Emergency and Individual Patient Use of Unapproved Drugs
Document Type:
Regulatory Guidance
Agency / Institution:
FDA, BMC/BUMC IRB
Author:
Not specified
Target Audience:
Healthcare professionals, Investigators, Physicians
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / City:
Lackawanna Trail School District
Subject:
School Board Meeting Minutes
Document Type:
Meeting Minutes
Organization / Institution:
Lackawanna Trail School District Board of Education
Author:
Board Members
Target Audience:
Board Members, District Staff, Public
Period of Action:
July 7, 2025
Approval Date:
Not approved
Modification Date:
Not indicated
Year:
2026
Region / City:
Earlham, Iowa
Subject:
Budget Planning and Allocation
Document Type:
Meeting Minutes
Organization / Institution:
Earlham City Council
Author:
Budget Committee
Target Audience:
City Council Members, Local Government Officials
Period of Action:
Fiscal Year 2026
Approval Date:
February 11, 2026
Amendment Date:
N/A
Year:
2025
Region / City:
Andhra Pradesh
Topic:
Urban Development
Document Type:
Government Order
Authority:
Government of Andhra Pradesh
Author:
S. Suresh Kumar, Principal Secretary to Government
Target Audience:
Municipalities, Urban Development Authorities, Government Officials
Effective Period:
From 26-07-2025
Approval Date:
26-07-2025
Amendment Date:
26-07-2025
Year:
2024
Region / City:
Big Pine
Topic:
Board meeting minutes
Document Type:
Meeting minutes
Organization / Institution:
Big Pine Community Services District
Author:
BryAnna Vaughan, Gary Doyel, Walt Sharer, Kent Schlick, Denise Tetrick
Target Audience:
Board members, contractors, administrative staff
Period of Validity:
May 15, 2024
Approval Date:
Not approved
Date of Changes:
May 15, 2024
Contextual Description:
Meeting minutes from the Big Pine Community Services District board meeting held on May 15, 2024.
Year:
2024
Region / City:
Big Pine
Topic:
Community Services District Board Meeting
Document Type:
Meeting Minutes
Organization:
Big Pine Community Services District
Author:
Denise Tetrick
Target Audience:
Board Members, Community Members
Period of Validity:
January 17, 2024
Approval Date:
January 17, 2024
Amendment Date:
None
Year:
2025
Location:
Richford, Vermont, USA
Document type:
Meeting minutes
Governing body:
Town of Richford Selectboard
Chair:
Steinhour
Attendees:
Andy Pond, Kristin Sheperd, Sherry Paquette, Alan Fletcher, Town Clerk Kiley Deuso, Karen Cangelosi, Whitney Benzing, Drew Gingras, Jon Wood, James Kleckan, Mark Jaffee, Robert Wetherby, Gerry Vaisey
Topics covered:
TAP Final Scoping Report, zoning issues, water plant security, road and building maintenance, parks, cemeteries, planning applications, executive session
Decisions made:
Approval of previous minutes, purchase of cameras, term extensions, sending violation letters, permissions for bus shelters, executive session for contractual matters
Meeting start time:
5:00 pm
Meeting end time:
6:20 pm
Submission:
Karen Cangelosi
Year:
2025
Document Type:
Worksheet
Purpose:
Emergency use of unapproved drugs, biologics, or devices
Audience:
Investigators and Designated Reviewers
Regulatory Reference:
FDA IND, 21 CFR §50
Scope:
Life-threatening or severely debilitating conditions
Approval Requirement:
IRB reporting within 5 working days
Consent Requirement:
Informed consent from patient or legally authorized representative, exceptions documented
Certification:
Physician uninvolved in investigation must certify when consent cannot be obtained
Document ID:
HRP-322
Related Documents:
HRP-310, HRP-314, HRP-506
Year:
2024
Region / City:
Big Pine, Inyo County, California, USA
Document Type:
Meeting Minutes
Organization:
Big Pine Community Services District
Attendees:
BryAnna Vaughan, Gary Doyel, Kent Schlick, Breeanna Ralston, Kevin Bigham, Denise Tetrick, Dave Tanksley, Christie Martindale, Jen Roeser
Absent:
Colleen Randolph
Topics Discussed:
Sewer disconnection, budget presentation, public comments, bills and warrants, old and new business, updates on water and sewer system, grants, and regulatory compliance
Next Meeting:
January 15, 2025
Document Status:
Unapproved
Source Type:
Administrative record
Meeting Start Time:
6:00 PM
Meeting Adjournment Time:
8:10 PM
Minutes Prepared By:
Denise Tetrick
Date:
March 20, 2024
Location:
Big Pine Community Services District
Topic:
Board meeting minutes
Document type:
Meeting minutes
Organization:
Big Pine Community Services District
Author:
Denise Tetrick, Administrative Services Manager
Target audience:
Board members, district staff, stakeholders
Approval date:
Pending
Next meeting:
April 17, 2024
Year:
2014
Country:
Belgium
Legislation:
Royal Decree of 14/12/2006 as amended by Royal Decree of 25/04/2014
Type of document:
Regulatory guidance
Target audience:
Pharmaceutical companies, healthcare professionals
Subject:
Compassionate use programs and medical need programs
Procedures included:
Submission process, dossier requirements, publication information, labeling, pharmacovigilance
Reference:
Regulation 726/2004, Article 6
Year:
2022
Region / City:
Not specified
Topic:
Compassionate love, family dynamics, psychological studies
Document Type:
Supplemental materials
Author:
Not specified
Target Audience:
Researchers in psychology, particularly those studying family relationships and compassionate love
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Study 1:
Parents of children under the age of 18
Study 2:
Parents of adult children (over 18 years)
Study 3:
Not specified
Study 4:
Focus on mothers of different ages
Study 7:
Replication of previous study by Collins et al. (2014)
Methodology:
Surveys, scales (Compassionate Love Scale)
Study Sample Size:
Study 1 - ~200 participants, Study 2 - ~200 participants, Study 4 - 555 participants
Compassionate Love Scale:
6-item and 21-item versions used
Access to Data:
Available on Open Science Framework
Study Details:
Detailed education and income descriptors for studies 1 and 2 provided
Description:
Supplementary materials for studies on compassionate love and beneficence within family dynamics, including sample size considerations, scales used, and demographic data.
Year:
2020
Region / city:
Africa
Topic:
Compassionate use of investigational medicinal products
Document type:
Guideline
Institution:
African Vaccine Regulatory Forum (AVAREF)
Author:
AVAREF
Target audience:
National regulatory authorities, public health organizations, medical professionals
Effective period:
Ongoing
Approval date:
February 2021
Modification date:
N/A
Year:
2020
Region / City:
Africa
Topic:
Compassionate Use of Medicines
Document Type:
Guidance
Organization / Institution:
African Vaccine Regulatory Forum (AVAREF)
Author:
AVAREF
Target Audience:
Regulatory Authorities, Health Organizations
Validity Period:
N/A
Approval Date:
June 15, 2020
Amendment Date:
July 24, 2020
Year:
2024
Region / City:
Belgium
Topic:
Compassionate use programs, medical need programs
Document Type:
Guidance
Organization / Institution:
FAMHP (Federal Agency for Medicines and Health Products)
Author:
FAMHP
Target Audience:
Medical professionals, pharmaceutical companies, regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Context:
This document provides guidelines for the application processes and requirements for compassionate use and medical need programs in Belgium, outlining submission formats, necessary documentation, and approval procedures.
Note:
Year
Theme:
Mental Health / Compassionate Mind Training
Document Type:
Handout
Organization:
Compassionate Mind
Target Audience:
Individuals, Clients, Mental Health Professionals
Location:
Anglesey (Ynys Môn)
Region:
Wales
Country:
United Kingdom
Language:
English
Type of document:
Interview transcript
Format:
Time-coded video transcript
Main topic:
Council leadership strategy and organizational culture
Key themes:
Compassionate leadership, learning culture, staff wellbeing, performance review, service delivery to children and families
Institutions mentioned:
Local council on Anglesey
Target group:
Council staff, children and families on Anglesey
Time frame referenced:
Several years of implementation
Indicators mentioned:
Staff sickness reduction, decreased reliance on agency staff, lower staff turnover, improved consistency of practice