№ lp_1_2_51243
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This guidance document outlines regulatory principles for classifying products as medicines, medical devices, or biologicals in Australia, specifically addressing boundary and combination products that may fall under multiple definitions.
Year:
2022
Region / city:
Australia
Topic:
Therapeutic Goods Regulation
Document type:
Guidance
Organization:
Therapeutic Goods Administration (TGA)
Author:
Commonwealth of Australia
Target audience:
Sponsors, manufacturers, and regulatory professionals
Validity period:
Not specified
Approval date:
October 2022
Date of changes:
Not specified
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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:
USA
Subject:
Medicare Part B Drugs and Biologicals ASP Data Reporting
Document Type:
Regulatory
Organization / Institution:
Centers for Medicare & Medicaid Services (CMS)
Author:
Centers for Medicare & Medicaid Services (CMS)
Target Audience:
Manufacturers of Medicare Part B Drugs and Biologicals
Period of Effect:
From January 1, 2022
Approval Date:
Not specified
Amendment Date:
November 5, 2025
Year:
2021
Jurisdiction:
Australia
Document type:
Regulatory order
Subject:
Standards for biological therapeutic goods
Authority:
Minister for Health and Aged Care
Responsible body:
Department of Health
Commencement date:
30 September 2021
Scope:
Human musculoskeletal, cardiovascular, ocular, skin, and amnion tissue products
Legal basis:
Therapeutic Goods Act 1989
Status:
Draft at the time of excerpt, not for signature
Year:
2021
Region / City:
Australia
Subject:
Biologicals, Labelling Requirements
Document Type:
Regulatory Guidelines
Organization / Institution:
Therapeutic Goods Administration (TGA)
Author:
Therapeutic Goods Administration (TGA)
Target Audience:
Manufacturers and sponsors of biologicals
Effective Period:
From 30 September 2021
Approval Date:
May 2021
Revision Date:
Not specified
Year:
2013
Region / City:
Washington, D.C.
Topic:
Foreign-Trade Zones (FTZ) Application
Document Type:
Instruction Sheet
Agency / Institution:
U.S. Department of Commerce, International Trade Administration
Author:
FTZ Staff
Target Audience:
Corporations and grantees applying for FTZ designation
Period of Action:
N/A
Approval Date:
March 2013
Amendment Date:
N/A
City:
City of Horseshoe Bay
State:
Texas
Department:
Development Services Department
Division:
Development Projects, Permits, and Inspections
Related Bodies:
Planning and Zoning Commission; Board of Adjustment; City Council
Document Type:
Administrative application
Subject:
Amendment to zoning ordinance; rezoning; zoning district boundary change
Jurisdiction:
City of Horseshoe Bay, Texas
Address:
1 Community Drive, P.O. Box 7765, Horseshoe Bay, TX 78657
Contact Phone:
830-598-9959
Application Scope:
Rezoning and text amendment requests
Requirements:
Ownership certification; application fee; site plan; plat or survey; public notice; attendance at hearings
Public Notice:
Newspaper publication and mailed notice to property owners within 200 feet
Approval Authority:
Development Services Director; Planning and Zoning Commission; City Council
Year:
2018
Region / City:
Odessa, Texas
Topic:
Land annexation
Document type:
Ordinance
Author:
City Council of Odessa
Target audience:
Residents and property owners in Odessa, Texas
Period of validity:
Not specified
Approval date:
October 9, 2018
Amendment date:
October 23, 2018
Contextual description:
This document is an official ordinance detailing the annexation of land into the city limits of Odessa, Texas, and the associated service plan.
Year:
2021
Region / City:
North East England
Theme:
Mental Health Act, Cross-Boundary Working
Document Type:
Practice Guidance
Organization / Institution:
Local Authorities (LSSAs) in the North East Region
Author:
Not specified
Target Audience:
Approved Mental Health Professionals (AMHPs), Local Authority Managers, Mental Health Service Providers
Period of Validity:
Ongoing
Approval Date:
September 2021
Review Date:
August 2022
Note:
Year
Topic:
Boundary Line Adjustment
Document Type:
Checklist
Target Audience:
Applicants for boundary line adjustments
Note:
Year
Topic:
Software Development, System Analysis
Document Type:
Instructional Guide
Target Audience:
Business Analysts, Software Developers, Stakeholders
Year:
2014
Region / City:
Bury
Theme:
Child protection, Children’s performances
Document Type:
Application form
Organization / Institution:
Bury Council
Author:
Bury Council
Target Audience:
Organisations applying for exemption from regulations
Period of validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Contextual Description
Year:
2025
Region / City:
Delaware
Topic:
Fire protection and district boundaries
Document Type:
Legal decision
Agency / Institution:
Delaware State Fire Prevention Commission
Author:
Ronald Marvel, William Kelly, Lynn Truitt, J. David Majewski, Sr., Joe Leonetti, Sr., Ronald O’Neal, Jeffrey Eisenbrey
Target Audience:
Local government officials, fire service personnel, legal professionals
Period of Effect:
2025
Approval Date:
April 16, 2025
Amendment Date:
Not applicable
Year:
2019
Region / City:
Florida
Topic:
Environmental Protection
Document Type:
Guidance Document
Agency / Institution:
Florida Department of Environmental Protection
Author:
Florida Department of Environmental Protection, Division of Waste Management
Target Audience:
FDEP staff, responsible parties, owners, consultants, lawyers
Period of Validity:
Not specified
Approval Date:
June 2019
Modification Date:
Not specified
Note:
Year
Author:
Sheng Fan, John Wheeler, David J. Prior, Marianne Negrini, Andrew J. Cross, Travis F. Hager, David L. Goldsby, David Wallis
Jurisdiction:
Resident Magistrates’ Courts
Subject Matter:
Boundary disputes and related land disputes
Legal Framework:
Judicature (Resident Magistrates) Act, Section 97
Related Provisions:
Section 98; Section 101; Section 104 of Law 28 of 1904 (now Section 101 of Cap 179); Law 39 of 1927, Section 102
Procedure Type:
Special statutory proceedings
Key Legal Concepts:
Boundary plaint; question of title; reference to surveyor; easements; rights of way
Judicial Authorities Cited:
Whitelocke vs. Campbell (1970) 12 J.L.R. 67; Cox v. Shields (1909) 9 S.C.J.B. 89; 1 Stephens Reports 352; McNish v. Murray (1924) Adrian Clark’s Reports 161; Holmes v. Ricketts (1879) 2 Stephens’ Reports
Court Officers Involved:
Resident Magistrate; Parish Judge; Commissioned Surveyor
Nature of Proceedings:
Civil proceedings concerning adjoining lands
Scope of Application:
Disputes concerning boundary lines, rights of way, water rights, and other easements affecting land
Date:
30 January 2026
Contact:
Greer Dewdney
Organisation:
Greater London Archaeological Advisory Service
Location:
Hounslow, London
Subject:
Archaeological consultation response
Planning application reference:
P/2026/0190
Listed building consent reference:
P/2026/0146
Archaeological assessment conclusion:
No archaeological requirement
Planning policy reference:
National Planning Policy Framework 2024, London Plan 2021 Policy HC1
Archaeological Priority Area:
Hounslow APA 2.7 Isleworth and Thames Foreshore
Region:
London and South East
Adviser:
Greer Dewdney
Service:
Archaeology Advice
Type of document:
Archaeological advisory response
Author:
Sahmiar Pulungan
Institution:
Universitas Islam Negeri Sumatera Utara, Medan, Indonesia
E-mail:
[email protected]
Thematic Focus:
Fiqh, Aurat, Hijab, Islamic Law, Dignified Society
Type of Document:
Academic journal article
Research Method:
Descriptive qualitative research with library research approach
Data Sources:
Primary sources (books); Secondary sources (journals)
Data Collection Technique:
Documentation method
Data Analysis Technique:
Miles and Huberman model
Religious References:
Surah An-Nur verses 30–31; Surah Al-Ahzab verse 59
Subject of Discussion:
Boundaries of women’s aurat in Islamic jurisprudence
Intended Audience:
Scholars, students, and readers of Islamic studies
Geographical Context:
Indonesia
Year:
2026
Region / City:
Global
Topic:
Climate Change, Carbon Cycle, Geology
Document Type:
Scientific Research
Institution:
Fujian Normal University, Macquarie University
Authors:
Mingming Ma, Mengdi Wang, Huixin Huang, Xiuming Liu
Target Audience:
Scientists, Researchers, Academics
Period of Effectiveness:
Cretaceous-Palaeogene boundary
Approval Date:
2026
Modification Date:
None
Year:
2024
Regulatory authority:
Therapeutic Goods Administration (TGA)
Medicine:
MACITENTAN 10 mg with TADALAFIL 40 mg (Opsynvi®)
Indication:
Pulmonary arterial hypertension (PAH), WHO Group 1, functional class II and III
Therapy type:
Dual or triple combination therapy
Dosage form:
Tablet, fixed dose combination (FDC)
Prescriber type:
Medical practitioners
Restriction type:
Authority Required (Written, Complex Authority Required)
Clinical criteria:
Treatment as dual therapy (MAC+TAD) or triple therapy with prostanoid
Population:
Adult patients with stable PAH on separate doses of macitentan and tadalafil
Previous considerations:
PBAC recommendations for macitentan and tadalafil since 2011–2014
Approval date:
16 September 2024
Source documents:
TGA registration, PBAC meeting minutes, ACM minutes August 2024, FDA, EMA, CDA references