Articles

Pharmacy software vendor links to TGA adverse event reporting web service

Medical Devices Safety Update, Volume 2, Number 3, May 2014

Approval of the Therapeutic Goods

Approval of the manner of making requests under subsection 9D(3) of the Therapeutic Goods Act 1989 to vary the entry in the Australian Register of Therapeutic Goods of registered therapeutic goods

Consultation on low value turnover exemption (LVT) scheme

The TGA reviewed studies on tartrazine, a yellow colouring used in medicines, and found it safe when properly labelled, with no strong evidence of harm like allergies or behavioural issues.

Pilot web service for transmission of adverse event reports from medical software to the Therapeutic Goods Administration

Medical Devices Safety Update, Volume 2, Number 1, January 2014

The TGA is advising consumers against purchasing or using black salve, red salve or cansema products.

Medicines Safety Update, Volume 4, Number 4, August 2013

Mifepristone and misoprostol can be prescribed in Australia by registered medical practitioners.

The TGA Prescription Medicines Streamlined Submissions Process Newsletter [formerly the Prescription medicine BPR update (BPR update)] reports on progress of the streamlined submission process.

The Prescription medicine BPR update (BPR update) reports on progress of the streamlined submission process. Each quarter, an update is provided on the PI/CMI project and the AusPAR project.