№ lp_1_2_43975
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The document outlines regulatory procedures for the emergency and individual patient use of unapproved investigational drugs, including steps for submitting requests to the FDA and obtaining approval from relevant authorities.
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
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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:
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:
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
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:
2023
Note:
Region / City
Subject:
Billing Requirements for Drugs and Biologicals with Discarded Amounts
Document Type:
Policy
Organization / Institution:
SummaCare, Apex Summa Health Management Company, Summa Insurance Company
Target Audience:
Providers, Healthcare Administrators, Claims Department
Effective Period:
From 01/01/2017
Approval Date:
08/15/2023
Review Date:
Every 2 years or as necessary
Compliance Statement:
All members of the workforce are responsible for compliance with this policy.
Monitoring and Auditing:
Claims Department
Documentation Retention:
Minimum of 10 years
Purpose:
To outline the billing requirements for drugs and biologicals with unused and discarded amounts from single-dose containers or single-use packages.
Description:
Guidelines on proper billing procedures for drugs and biologicals, including the use of JW and JZ modifiers for discarded drug amounts or no wastage in single-dose vials, applicable to providers and insurers.
Year:
2025
Region / City:
Not specified
Theme:
Healthcare, Drug Coverage
Document Type:
Informational Flyer
Organization / Institution:
Wellcare
Author:
Not specified
Target Audience:
Healthcare providers, insurance plan members
Period of Validity:
Not specified
Approval Date:
07/24/2024
Date of Changes:
Not specified
Year:
2021
Region / City:
Australia
Theme:
Mental health, Alcohol and Other Drugs
Document Type:
Unit of competency
Organization / Institution:
Australian Skills Quality Authority (ASQA)
Author:
Not specified
Target Audience:
People working in community services, mental health and alcohol and other drug sectors
Period of validity:
Not specified
Approval Date:
Not specified
Date of modifications:
Release 2, Modification History: Release 2
Note:
Year
Topic:
Clinical Trial Agreement
Document Type:
Contract
Institution / Organization:
Istituto clinico Humanitas
Target Audience:
Medical, Scientific, and Research Professionals
Unit code:
CHCAOD007
Release:
2
Type:
Competency unit
Sector:
Health and community services
Target group:
Workers supporting people with alcohol and other drug challenges
Application:
Relapse prevention and management strategies
Legislation and standards:
Commonwealth and State/Territory legislation, Australian/New Zealand standards, industry codes of practice
Skills:
Relapse prevention planning, risk assessment, harm minimisation, communication, crisis management
Assessment:
Workplace demonstration or simulated environment, treatment plans, risk assessment tools
Knowledge:
Legal and ethical considerations, AOD effects and responses, relapse triggers, support strategies, therapy options, environmental and individual risk factors
Year:
2023
Region:
Scotland
Jurisdiction:
Scotland
Topic:
Management of controlled drugs in primary care
Document type:
Guidance
Version:
3.0
Publication date:
April 2023
Issuing body:
Controlled Drugs Accountable Officers’ Network Scotland
Contributing organisation:
NHS Dumfries & Galloway
Foreword author:
Graeme Bryson
Author role:
Director of Pharmacy
Target audience:
Practitioners working within primary care
Legal framework referenced:
Misuse of Drugs Act 1971; Misuse of Drugs Regulations 2001; Controlled Drugs (Supervision of Management and Use) Regulations 2013
Scope:
Prescribing, supply, administration, storage, recording, monitoring and destruction of controlled drugs
Source type:
Official professional guidance
Note:
Year
Topic:
Incident Reporting
Document Type:
Report Form
Organization:
NHS
Target Audience:
NHS Staff, Contractors