Latest Therapeutic Goods Administration News

CSIRO opens ‘missing link’ lab to developing Australian vaccine pipeline
Enviro Tech Holdings and company officers ordered by Federal Court to pay $96,000 for unlawful importation of surgical face masks
2San Pty Ltd fined $66,600 for allegedly failing to provide ongoing evidence to support performance of its Covid rapid antigen tests
Enhertu approved in US as first HER2-directed therapy for patients with HER2-low metastatic breast cancer
ATAGI update following weekly Covid meeting 4 August
Who is at fault when medical software gets it wrong?
How do epidurals work? And why is there a global shortage of them?
ATAGI recommendations on Covid vaccine use in children aged 6 months
TGA commences evaluation of Pfizer’s Covid vaccine for children aged 6 months to less than 5 years
NSW individual fined $2,664 for alleged unlawful advertising of nicotine vaping products
Phenix Health Pty Ltd directed to cease alleged unlawful advertising of nicotine vaping products
Advice on use of nirmatrelvir + ritonavir post labelled expiry date
What allegations of Alzheimer’s research fraud mean for patients
New pancreatic cancer treatment available
ATAGI update following weekly Covid meeting 29 July
Rapid Antigen Test cancellations not due to failure to detect Covid Omicron variant
Strapit Medical and Sports Supplies Pty Ltd undertakes to comply with advertising rules for therapeutic goods
Court proceedings initiated against Vapor Kings Pty Ltd and its director for alleged unlawful advertising of nicotine vaping
TGA provisionally approves Biocelect Pty Ltd Covid vaccine, NUVAXOVID, for use in individuals aged 12
13 Vape Pty Ltd directed to cease alleged unlawful advertising of nicotine vaping products
International consultation on medical device cybersecurity
ATAGI update following weekly Covid meeting 21 July
Person fined $31,698 for alleged unlawful advertising of disposable nicotine vaping products
TGA decision on children’s vaccination welcomed, but national uniformity needed
GP knowledge gaps regarding Zostavax use in immunocompromised people remain concerning, study finds
TGA provisionally approves Moderna Covid vaccine for use in children from 6 months
Shortage of tocilizumab medicines: Resolved
Shortage of tenecteplase
First-generation antihistamines – winter warning
Surrogate viruses for use in disinfectant efficacy tests to justify claims against Monkeypox
Home use fetal dopplers
Lucas’ Papaw Ointment
TGA grants provisional determinations to Pfizer for Covid vaccines to target Omicron variant
ATAGI update following weekly Covid meeting 5 July
Medtronic MiniMed 600 and 700 series Insulin Pumps
Shortage of abatacept medicines: Resolved
Instagram pressure rising
Precision Pharmaceuticals Pty Ltd fined and directed to cease alleged unlawful advertising of nicotine vaping products
Top 3 questions – Oral Treatments for Covid
New leadership for medtech regulatory advisory group
Provisional determination granted to Pfizer in relation to COVID 19 vaccine, COMIRNATY
Cancer Council warns urgent intergovernmental action is essential to stop an epidemic of e-cigarette use among young people
Hough Pharma Pty Ltd fined $106,560 for allegedly failing to provide information to demonstrate adequate performance of three Covid
HERO Instant Energy for Males capsules
T:slim X2 Insulin Pump
Court proceedings initiated against Prefixx Pty Ltd and its director for alleged unlawful advertising of nicotine vaping products
Transition period from 2018 to 2021 Advertising Code ends 30 June 2022
Individual fined $2,664 for allegedly advertising unapproved therapeutic goods