№ files_lp_4_process_3_104426
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Character count: 4834
File size: 111 KB
Structured guidance for investigators and reviewers detailing criteria, consent requirements, and documentation procedures for emergency use of unapproved medical products.
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
Price: 8 / 10 USD
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Note:
Year
Subject:
Pharmaceutical Quality Information Summary
Document Type:
Template
Agency / Institution:
SAHPRA
Note:
Year
Theme:
Data Integrity, Pharmaceutical Industry, Biologics
Document type:
Code of Conduct
Organization / institution:
Parenteral Drug Association (PDA)
Author:
Parenteral Drug Association (PDA)
Target audience:
Pharmaceutical and Biologics Industry Professionals
Year:
2018
Region / City:
Fredericksburg, VA
Topic:
Biologics, Contracting, Medical Supplies
Document Type:
Contract Award Notice
Agency:
U.S. Department of Veterans Affairs
Author:
Not specified
Target Audience:
Contractors, Veterans Affairs
Period of Action:
From September 27, 2018
Approval Date:
September 27, 2018
Date of Changes:
Not specified
Year:
2023
Region / City:
Oxon Hill, Maryland
Topic:
Biologics, Biotechnology, Veterinary Health
Document Type:
Meeting Minutes
Organization:
USAHA Committee on Biologics and Biotechnology
Author:
Committee members and speakers
Target Audience:
Veterinary professionals, industry representatives, regulatory bodies
Period of Activity:
October 17, 2023
Approval Date:
October 17, 2023
Date of Changes:
Not indicated
Year:
Not specified
Region / City:
Not specified
Topic:
Pharmaceutical products, Drug validation
Document type:
Checklist
Organization / Institution:
MDA (Malaysian Drug Authority)
Author:
Not specified
Target audience:
Pharmaceutical companies, regulatory authorities
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Language:
English
Keywords:
Drug product, Biologics, Validation, Pharmaceutical, Medical device
Year:
2013
Region / City:
EU
Subject:
Biologics, Biotechnology, Clinical Trials, Market Authorization
Document Type:
Clinical Trial and Market Authorization Process Overview
Organization:
NCL Innovations
Author:
NCL Innovations
Target Audience:
Healthcare professionals, regulatory bodies, pharmaceutical companies
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2026
Region / City:
Not specified
Document Type:
Patient Directive / Legal Statement
Institution:
Hospital or affiliated medical facility
Author:
Patient (name not specified)
Target Audience:
Medical staff, legal representatives
Date of Document:
2026-03-06
Purpose:
To formally refuse vaccines, biologics, and biogenics during hospitalization
Method of Consent:
Signed by patient in presence of witnesses
Notarization:
Optional, recommended for legal validation
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:
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:
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