№ lp_1_31002
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This guidance document outlines the requirements for donor screening for human cell or tissue products under the Therapeutic Goods Order 108 (TGO 108), focusing on minimizing infectious disease transmission risks.
Year:
2021
Region / City:
Australia
Topic:
Biologicals, Human Cell and Tissue Products, Donor Screening
Document Type:
Guideline
Agency:
Therapeutic Goods Administration (TGA)
Author:
Therapeutic Goods Administration (TGA)
Target Audience:
Manufacturers and Sponsors of Biological Products
Effective Period:
2021
Approval Date:
May 2021
Amendment Date:
N/A
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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:
2021
Region / City:
Australia
Topic:
Vaporiser Nicotine Product Standards
Document Type:
Legislative Instrument
Organization / Institution:
Department of Health
Author:
[Name of delegate]
Target Audience:
Manufacturers, Health Authorities, Regulatory Bodies
Period of Validity:
From 1 October 2021
Approval Date:
1 October 2021
Amendment Date:
Not specified
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:
2021
Region / city:
Australia
Topic:
Vaporiser nicotine regulation
Document type:
Consultation paper
Agency / institution:
Therapeutic Goods Administration (TGA)
Author:
Commonwealth of Australia
Target audience:
Industry stakeholders, health professionals, general public
Period of validity:
Until TGO 110 is finalized
Approval date:
Expected April or May 2021
Amendment date:
Not specified
Note:
Context
Note:
Year
Region / City:
Singapore
Subject:
Resignation of Auditor, Variable Capital Companies
Document Type:
Application Form
Organization / Institution:
Accounting and Corporate Regulatory Authority (ACRA)
Target Audience:
Public accountants and auditors of Variable Capital Companies (VCCs)
Year:
2020
Region / City:
Los Angeles
Subject:
Real Estate Investigation
Document Type:
Duty Statement
Agency / Organization:
Department of Real Estate
Author:
Department of Real Estate
Target Audience:
Department employees and potential candidates
Effective Date:
Not specified
Date of Approval:
Not specified
Date of Amendments:
07/2020
Year:
2023
Location:
Toulouse, France
Topic:
NR FR1 TRP TRS measurement and methodology
Document type:
Meeting summary
Organization:
3GPP TSG-RAN WG4
Contributors:
Huawei Tech., Rohde & Schwarz, Apple, Keysight Technologies, Samsung, vivo
Agenda item:
8.15.4
TRP/TRS Work Item:
Rel-18 FR1
Test methodology:
Anechoic chamber testing, UL MIMO, TxD considerations
Recommendations:
TPMI index selection, test-time optimization, EIRP measurement
Year:
2023
Region / City:
N/A
Subject:
Identity Management
Document Type:
User Guide
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Users of IDM System
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2020
Region / City:
Australia
Theme:
Pharmaceutical submission, medical treatment
Document Type:
Submission
Organization / Institution:
Takeda Pharmaceuticals Australia Pty Ltd
Author:
Takeda Pharmaceuticals Australia Pty Ltd
Target Audience:
Medical practitioners, gastroenterologists
Period of Validity:
Not specified
Approval Date:
12 May 2020
Modification Date:
Not specified
Registration Status:
Registered by TGA
Clinical Claim:
VDZ SC is as effective as VDZ IV for maintenance treatment in MSUC and severe CD
Indications:
Treatment for moderate to severe ulcerative colitis and Crohn’s disease
Requested Listings:
PBS listing for VDZ SC as maintenance treatment
Prescriber Instructions:
Specific guidelines for initiating subcutaneous therapy
Administrative Advice:
Applications for authorisation under PBS can be made online or by phone
Contextual Description:
A pharmaceutical submission for the approval of vedolizumab (VDZ SC) as a maintenance treatment for moderate to severe ulcerative colitis and severe Crohn’s disease based on a cost-minimisation analysis.
Document Number:
FCC 22-24
Release Date:
March 21, 2022
Docket Number:
AU Docket No. 20-429
Issuing Authority:
Federal Communications Commission
Bureaus:
Office of Economics and Analytics; Wireless Telecommunications Bureau
Subject:
Competitive bidding procedures for flexible-use licenses in the 2.5 GHz band
Auction Title:
Auction 108
Scheduled Bidding Start Date:
July 29, 2022
Spectrum Band:
2.5 GHz
Spectrum Amount:
117.5 megahertz
Number of Licenses:
Approximately 8,000 geographic overlay licenses
Auction Format:
Ascending clock auction (clock-1 format)
Related Proceeding:
2.5 GHz Report and Order
Applicable Law:
Communications Act of 1934, section 309(j)
Forms Referenced:
FCC Form 175; FCC Form 159; FCC Form 601; FCC Form 602
Public Notice Type:
Procedures, terms, conditions, dates, and deadlines for participation
Jurisdiction:
Oregon
Measure Name:
Ballot Measure 108
Legislative Reference:
HB 2270 (2019 session)
Subject:
Tobacco and inhalant delivery system taxation
Type of Document:
Fiscal and policy summary
Source:
Legislative Fiscal Office
Affected Products:
Cigarettes, little cigars, cigars, inhalant delivery systems
Proposed Cigarette Tax Increase:
$2.00 per pack of 20 cigarettes
New Cigarette Tax Rate Effective Date:
January 1, 2021 (if approved)
Inhalant Delivery System Tax Rate:
65% of wholesale price
Cigar Tax Cap Increase:
From $0.50 to $1.00 per cigar
Revenue Allocation:
90% to state medical assistance program; 10% to tobacco prevention, cessation, and management of tobacco-related health conditions
Estimated Revenue 2019–2021:
$115 million
Estimated Revenue 2021–2023:
$350.4 million
Estimated Revenue 2023–2025:
$351.1 million
Year:
2012
Course:
Compsci 108
Type of document:
Exam paper
Author:
Unknown
Target audience:
Students of Compsci 108
Period:
Spring 2012
Date of approval:
N/A
Date of changes:
N/A
Note:
Context
Year:
2025
Location:
Prague, Czech Republic
Topic:
NR Mobility Enhancements Phase 4
Document Type:
Status Report
Organization:
3GPP TSG RAN
Working Group:
RAN WG2
Rapporteur:
Naveen Palle
Company:
Apple Inc.
Email:
[email protected]
Agenda Item:
9.3.2.1
WI / SI Name:
NR mobility enhancements Phase 4
Core Part Target Completion:
09/2025
Performance Part Target Completion:
03/2026
Overall Completion Level:
Core 91%, Performance 0%
Study Item:
No
Testing Part:
No
Source:
Leading WG
Context:
Technical report detailing progress, agreements, and conclusions of 3GPP RAN working groups regarding NR mobility enhancements, including configuration and measurement specifications for candidate cells.
Year:
2023
City:
Toulouse
Country:
France
Meeting:
3GPP TSG-RAN WG4 Meeting #108
Agenda item:
8.18.1
Topic:
NR_demod_enh3_Part1 – Advanced Receiver for MU-MIMO
Technical field:
5G NR radio access network standardization
Document type:
Technical meeting contribution summary
Organization:
3GPP TSG-RAN WG4
Moderator / Source:
China Telecom
Contributing companies:
China Telecom; Apple; ZTE Corporation; Nokia; Nokia Shanghai Bell
Work item:
Rel-18 NR demodulation requirement evolution
Content focus:
Reference receiver selection, R-ML receiver assumptions, blind detection complexity, RRC signaling proposals, UE capability signaling, MU-MIMO demodulation performance evaluation
Target audience:
RAN4 participants and technical contributors involved in 5G NR standardization
Date of meeting:
August 21–25, 2023
Purpose:
Information
Year:
2020
Region / city:
N/A
Topic:
English grammar exercises
Document type:
Instructional material
Institution:
N/A
Author:
Mrs M
Target audience:
Students
Validity period:
N/A
Approval date:
N/A
Modification date:
N/A
Context description:
Instructional material with exercises on English grammar, including inversion, modal verbs, and verb tenses.
Year:
2026
Course:
PSY 108
Module:
Three
Document Type:
Academic activity template
Institution:
[Not specified]
Author:
[Not specified]
Target Audience:
Students enrolled in PSY 108
Subject:
Helping professions, self-care, emotional intelligence
Assignment Length:
1–3 sentences per response
Components:
Prompt review, supporting materials, reflection questions