Articles

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

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

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

A revised edition of the Uniform Recall Procedure for Therapeutic Goods has been published for consultation

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

Prescription medicines sponsors can now submit dossiers to the TGA in the electronic Common Technical Document (eCTD) format

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.

An overview of the process for determining the most effective composition for the annual influenza virus

Safety though adverse event reporting; Recommendations for avoiding or dealing with surgical implant tool breakages; IRIS inSite pilot off to promising start; Clinical alarm issues still pose top hazard; Recent safety alerts

Undertaking to the Secretary of the Australian Government Department of Health given for the purposes of section 42YL of the Act

The TGA and NPS Medicinewise have worked together to create two interactive online learning modules

The Australian and New Zealand Governments have agreed to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA).