Latest TGA News | Page 4

Federal 2023-24 Budget wrap up for biotech
Important safety information for Janus kinase (JAK) inhibitors
TGA publishes updated guidelines for sunscreens
EU MDR transition extension
Covid vaccine safety report – 04-05-23
Live vaccines – what are contraindications?
TGA makes final decision to reduce paracetamol pack sizes
Removal of prescribing restrictions on ivermectin
Mark Butler refuses to provide a guarantee to patients and community pharmacies
Supporting strong action to address harm caused by e-cigarettes
Surveys – Medical devices manufactured at Point-of-Care
Moderna’s COVID-19 vaccine SPIKEVAX receives approval for full registration
Regulatory changes for medical device clinical trials not needed
Covid vaccine safety report – 20-04-23
Infringement notices totalling $66,600 given to three Sydney-based companies and two individuals for alleged unlawful importation of nicotine vaping products
First Mpox test kit approved for Australia
New asthma medicine restrictions will hurt the poorest children the most
Covid vaccine safety report – 06-04-23
Dual labelled medicines begin transition to sole medicine ingredient names soon
Emyria and Aspen Australia sign binding licensing and commercialisation term sheet
Prior use of pholcodine-containing cough and cold remedies and risk of perioperative anaphylactic reactions to neuromuscular blocking agents (NMBAs)
Changes to medical device essential principles for nanomaterials
IDT achieves milestone with TGA-approved expansion of manufacturing
Company director sentenced to 2 years imprisonment with personal and company fines of over $ 2.5 million for selling illegal SARMs
TGA Product Information safety updates 27 March
TGA review strengthens case for much tighter vape restrictions at the border
TGA’s new powers will help reduce the impact of medicine shortages on patients
Vaping law changes imminent
Covid vaccine safety report – 23-03-2023
Lapse of provisional registration for Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic triple negative breast cancer (mTNBC)
Nubeqa registered by TGA for new patient group
New combination therapy for advanced prostate cancer secures TGA registration
GMP Clearance: Additional countries added to MRA pathway
Check for pholcodine use before general anaesthesia
JSHealth Vitamins fined $13,320 for alleged unlawful supply of a complementary medicine
Covid vaccine safety report – 09-03-2023
Australian manufacturer fined almost $160,000 for allegedly breaching conditions of its medicines manufacturing licence
TGA seizes more than 55,000 potentially dangerous products with the assistance of NSW Police
Emyria partners with specialist trauma psychiatric service to advance MDMA-assisted therapy
TGA Product Information safety updates 2 March
Update on effectiveness of monoclonal antibodies against COVID variants
Why cough medicines containing pholcodine can be deadly even if you took them months before surgery
Response to Pholcodine cough medicine recall
Consumers warned about Ozempic scams
Pholcodine cough medicines cancelled by the TGA and recalled from pharmacies for safety reasons
AusBiotech to propose overhaul of TGA funding
Supplies secured of latest Moderna COVID-19 vaccine as recommended by Halton Review
NSW pharmacy contraceptive trial shortcuts women’s health and safety