Articles

TGA issued a fine for alleged advertising of an unlisted complementary medicine after Junction Rx failed to comply with a cease and desist notice by the set deadline.

This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations

Information about the TGA's safety monitoring of COVID-19 vaccines

Access Consortium guidance for strain changes to COVID-19 vaccines

Information about the TGA's safety monitoring of COVID-19 vaccines

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

The TGA has issued two infringement notices to Perth-based company Bajaria Global Pty Ltd

Invitation to the National Measurement Institute's mask/respirator testing forum.

The TGA has issued four infringement notices for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

Federal Court finds Evolution Supplements Australia breached advertising laws

The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine

Mr Leyonhjelm was directed to cease advertising a prescription medicine for the treatment of Covid-19.

Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA)

The TGA has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.

Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 ceases on 31 January 2021.

Updated to include new section on Reprocessing of PPE by Healthcare facilities

The TGA has issued eight infringement notices to Sydney-based company for allegedly failing to provide information and face mask samples to the TGA when required to do so, and for providing false and misleading information.

Healthcare professionals and public health authorities will have a central role in discussing vaccination against COVID-19 with their patients.

The Therapeutic Goods (Permissible Indications) Determination has been updated

The TGA has granted a provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to the COVID-19 Vaccine, NVX-CoV2373.

In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine

The TGA has issued an infringement notice to Brisbane-based company PPE Direct Pty Ltd, trading as Infinity Biotech for the alleged unlawful advertising of a COVID-19 Rapid Test kit under the Therapeutic Goods Act 1989.

The TGA has issued an infringement notice to Melbourne-based company Enviro Tech Holdings Pty Ltd for the alleged unlawful importation of surgical face masks in relation to COVID-19.

The TGA is warning consumers that off-label use of so-called smart drugs, such as Modafinil, is not a wise choice.