Latest TGA News | Page 11

Q-Gen Cell Therapeutics leading the charge in revolutionary cell therapy research
Phase out of ISO 13485 certificates for IVD medical devices
Queensland individual fined nearly $16,000 after allegedly importing unregistered nicotine vaping products
Therapeutic Goods Instrument 2023
Instrument of arrangement: Use of computer program to make decisions, July 2018
Covid vaccine weekly safety report – 18-05-2023
GMP Clearance: Extension processing times
Updates to the Prescribing Medicines in Pregnancy database, May 2023
TGA targets unlawful importation of prescription medicines
Psychedelic therapies for some mental illnesses will soon be legal – but experts still have questions
Public health, medicine not forgotten
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