№ lp_2_3_60692
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This document outlines the rules and guidelines for the Powder Springs Youth Baseball Association, including responsibilities for teams, equipment handling, game conduct, and safety measures.
Year:
2022
Region / City:
Powder Springs, Georgia
Theme:
Youth baseball
Document Type:
Rules and guidelines
Organization / Institution:
Powder Springs Youth Baseball Association
Author:
Not specified
Target Audience:
Coaches, players, and parents involved in Powder Springs Youth Baseball
Period of Validity:
Indefinite
Approval Date:
Not specified
Amendment Date:
Fall 2022
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / city:
Australia
Topic:
Vedolizumab submission for chronic pouchitis treatment
Document type:
Submission for listing of medicinal product
Agency:
Therapeutic Goods Administration (TGA)
Author:
Takeda Pharmaceuticals Australia Pty. Ltd.
Target audience:
Healthcare professionals, regulatory authorities
Effective period:
From 29 June 2023
Approval date:
29 June 2023
Modification date:
N/A
Year:
2018
Region / City:
Australia
Topic:
Pharmaceutical Submission, Cancer Treatment
Document Type:
Submission
Organization / Institution:
Takeda Pharmaceuticals Australia Pty Ltd
Author:
Takeda Pharmaceuticals Australia Pty Ltd
Target Audience:
Healthcare professionals, PBAC
Period of Validity:
Ongoing
Approval Date:
23 May 2018
Date of Amendments:
Not specified
Year:
Not specified
Region / city:
Tanzania
Topic:
Food safety
Document type:
Standard
Agency / institution:
Tanzania Bureau of Standards
Author:
Not specified
Target audience:
Not specified
Period of validity:
Not specified
Date of approval:
Not specified
Date of amendments:
Not specified
Context description:
This document outlines the specifications, sampling, and test methods for spiced seaweed powder produced from edible seaweed species intended for human consumption, issued as a national standard.
Year:
2024
Region / city:
Australia
Topic:
Thyroid eye disease (TED), Medical treatment, Drug submission
Document type:
Submission for drug listing approval
Organization:
PBAC, TGA
Author:
AMGEN AUSTRALIA PTY LTD
Target audience:
Medical practitioners, regulatory bodies
Period of validity:
Ongoing
Approval date:
Not yet decided
Amendment date:
December 2024
Clinical criteria:
Active, moderate-to-severe thyroid eye disease, CAS ≥ 3, specific treatment criteria
Indication:
Active, moderate-to-severe thyroid eye disease
Prescriber type:
Medical practitioners
Treatment phase:
Initial, Continuing
Category / Program:
Section 100, Authority Required (Streamlined)
Product:
Teprotumumab (Tepezza)
Comparator:
IV methylprednisolone, tocilizumab
Clinical claim:
Superior efficacy, non-inferior safety to standard treatments
Outcome measures:
Proptosis, diplopia, quality of life, adverse events
Background:
Teprotumumab undergoing TGA review, with specific recommendations from the Advisory Committee on Medicines
Year:
2023
Region / city:
Australia
Type of document:
Pharmaceutical submission / Public Summary Document
Regulatory authority:
Therapeutic Goods Administration (TGA)
Submitted by:
Generic Health Pty Ltd
Product:
Tiotropium Lupin 18 microgram powder for inhalation, LupinHaler device
Indication:
Chronic obstructive pulmonary disease (COPD)
Previous PBS listing:
Spiriva 18 microgram powder for inhalation, HandiHaler device
Submission type:
Category 4 (cost-minimisation comparison)
PBS item code:
8626BMP,NP
Maximum quantity:
1 pack, 30 units
Prescriber type:
Nurse Practitioners, Medical Practitioners
Restriction type:
Restricted benefit
Administrative advice:
Not to be used in combination with LAMA/LABA or SAMA; adherence to current inhaler technique to be reviewed at each clinical visit; diagnosis requires spirometry confirmation
Year:
2024
Region / city:
Australia
Subject:
Urothelial cancer treatment
Document type:
Submission
Organization / institution:
TGA, PBAC
Author:
Not specified
Target audience:
Medical professionals
Period of validity:
2024–2026
Approval date:
Not specified
Date of changes:
Not specified
Year:
2024
Region / city:
Australia
Topic:
Dietary management of Phenylketonuria (PKU)
Document type:
Submission
Organization:
PBAC
Author:
Committee Secretariat
Target audience:
Medical practitioners, nurse practitioners
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2025
Region / city:
Australia
Topic:
Pharmaceutical submission
Document type:
Submission for PBS listing
Organ / institution:
Pharmaceutical Benefits Advisory Committee (PBAC), Medical Services Advisory Committee (MSAC)
Author:
AstraZeneca Pty Ltd
Target audience:
Medical professionals, healthcare policy makers
Effective period:
2025 onward
Approval date:
March 25, 2025
Date of changes:
September 10, 2024
Year:
2024
Region / City:
Australia
Topic:
Vaccine Approval, Respiratory Syncytial Virus
Document Type:
Clinical Submission
Organization / Institution:
GlaxoSmithKline Australia Pty Ltd
Author:
Unknown
Target Audience:
Health professionals, Policy makers
Effective Period:
Ongoing
Approval Date:
January 14, 2024
Change Date:
April 2024
Year:
2023
Region / City:
Australia
Topic:
Oncology, Drug Approval
Document Type:
Submission for Pharmaceutical Listing
Organization:
ASTRAZENECA PTY LTD
Author:
Unknown
Target Audience:
Healthcare professionals, regulatory bodies, oncology specialists
Effective Period:
2023
Approval Date:
January 2023
Modification Date:
Not specified
Treatment:
Trastuzumab deruxtecan (T-DXd)
Indication:
Unresectable and/or metastatic HER2-low breast cancer
Comparator:
Physician’s choice of chemotherapy, Sacituzumab govitecan
Outcome Metrics:
Overall survival, Progression-free survival, Objective response rate, Duration of response, Time to progression, Quality of life, Safety
Clinical Claim:
T-DXd demonstrates superior efficacy for HR positive/HER2-low BC, and non-inferior efficacy for HR negative/HER2-low BC, compared to other treatments.
Source:
Table 1-1, p47 of the submission.
Year:
2023
Region / City:
Australia
Topic:
Food for medical purposes, dietary supplements
Document Type:
Submission
Agency / Institution:
Vitaflo Australia Pty Limited
Author:
Not specified
Target Audience:
Healthcare professionals, pharmaceutical regulators
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2026
Region / City:
Australia
Topic:
Nutritional Formulation, Food for Special Medical Purposes
Document Type:
Submission to PBAC
Organization / Institution:
PBAC, Nutricia Australia Pty Ltd
Author:
Nutricia Australia Pty Ltd
Target Audience:
Healthcare professionals, regulatory bodies, pediatricians
Validity Period:
Ongoing
Approval Date:
1 August 2002
Date of Change:
2011, 2026
Requested Change:
Formulation modification to comply with EU regulations
Status:
Approved for continued listing
Year:
2021
Region / city:
Noordwijk, The Netherlands
Topic:
Space product assurance, metallic powder bed fusion technologies
Document type:
Standard
Organization / institution:
European Space Agency (ESA)
Author:
ECSS-Q-ST-70-80C Working Group
Target audience:
Space industry professionals
Effective period:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
2017
Region / city:
Australia
Theme:
Oncology, Immunotherapy
Document type:
Pharmaceutical Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Merck Sharp & Dohme
Target audience:
Healthcare professionals, medical practitioners
Effective period:
Ongoing
Approval date:
March 2017
Changes date:
Not specified
Context:
A pharmaceutical submission for the listing of pembrolizumab for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients, detailing proposed PBS listings, treatment phases, and clinical criteria.
Year:
Not stated
Region / City:
Australia
Subject:
Glutaric aciduria type 1 treatment
Document Type:
Application for restricted benefit listing
Organization / Institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Not stated
Target Audience:
Medical practitioners, nurse practitioners, optometrists, midwives
Period of validity:
Not stated
Approval Date:
Not stated
Date of Changes:
Not stated
Year:
2016
Note:
Region / City
Theme:
Sports
Document Type:
Tournament Rules
Target Audience:
Participants, Umpires, Organizers
Period of Validity:
August 6th, 2016 –
Description:
A set of rules and regulations for the Standard Lombard Premier League cricket tournament, detailing match conditions, player requirements, and penalty systems.
Year:
2025-2029
Region / City:
USA
Topic:
Ice Hockey, Player Safety, Fair Play
Document Type:
Rules and Regulations
Organization / Institution:
USA Hockey
Author:
USA Hockey
Target Audience:
Players, Coaches, Officials, Spectators, Volunteers
Period of Validity:
2025-2029
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Contextual Description
Year:
2025
Region / City:
N/A
Theme:
Softball, Youth Sports
Document Type:
Playing Rules and Guidelines
Organization:
USA Softball
Target Audience:
Coaches, Players, and Fans of 10U Softball
Period of Validity:
Spring 2025
Approval Date:
N/A
Date of Amendments:
N/A
Note:
Year
Organization / Institution:
Arlington Soccer Association
Contextual Description:
Administrative and regulatory rules for teams and participants in the Arlington Premier Invitational League, detailing eligibility, misconduct penalties, game durations, and team equipment.