Articles

Arrangement under section 7C of the Therapeutic Goods Act 1989 for use of computer programs to make decisions.

Information for consumers about finding potential allergens on medicine labels

Progressive multifocal leukoencephalopathy, aripiprazole and vemurafenib

In this issue: strategies for vena cava filter removal; ECRI lists infusion errors as top hazard; recent safety alerts

The codeine re-scheduling RIS and associated economic modelling report are now available

Approved manner for making an application under section 23 of the Therapeutic Goods Act 1989 in relation to the listing of export only medicine under section 26.

Repeals 48 former notices made between 2005 and 2015 that are no longer required

This response presents a strategic and systems-based approach to achieve long-term sustainable reform

Arrangement under section 7C(1) of the Therapeutic Goods Act 1889 for the use of computer program to make decisions in relation to the listing of medicines under section 26A and listing of kits for supply in Australia under section 26.

Approved manner for making applications under section 23(1)(a) of the Therapeutic Goods Act 1889 in relation to the listing of medicines under section 26A and listing of kits for supply in Australia under section 26.

In this issue: endoscope reprocessing; device cybersecurity a key issue; safely retaining devices; sponsor workshops; recent safety alerts

Make a request under section 9D of the Therapeutic Goods Act 1989.

Information about the TGA operations over the 2015/16 Christmas/New Year period

Stage two report for the Review of Medicines and Medical Devices has been released

Current funding arrangements to end on 31 March 2016

The Therapeutic Goods Administration has published an interim decision on a proposal to up-schedule codeine

Check 'synch' before cardioversion; Recognising medical device incidents; Grounding pad selection vital during electrosurgical and ablation procedures; Practice points - HIV point-of-care testing; Recent safety alerts

The TGA has imposed two new conditions on the inclusion of the SynchroMed II Programmable Pump in the Australian Register of Therapeutic Goods

In this issue: Action after registry data analysis; Environmental extremes; Button battery dangers; Infant sleep positioners reviewed

From 1 July 2015 commercial IVD medical devices will be monitored under the Regulatory Compliance Framework

From 1 July 2015, new guidance and forms for Additional trade names and Extensions of Indications applications will be available

Between 24 May and 16 June, the ACBPS, TGA and APVMA took part in an international crackdown on fake and illegal medicines

The TGA is aware of regulatory action undertaken by the US Food and Drug Administration (FDA) in relation to the Maquet manufacturing facility in Hudson, New Hampshire, USA

Next Tuesday we will be launching the new TGA Business Services site.