Articles

Therapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form

Information about influenza vaccines for use in 2018

In reference to the ABC’s Fact Check article “Will the move to make codeine prescription-only save a100 lives a year” the Therapeutic Goods Administration (TGA) would like to clarify:

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Preventable alarm issues; Review into cochlear implants; NHS cylinder alert; recent safety alerts

s23 instruments supporting the new COR process have been updated.

The medicines’ regulator is not proposing and will not be stopping GPs from prescribing high dose opioids

The TGA has issued a discussion paper on the use and misuse of prescription strong opioids, such as oxycodone, and whether there is a need for specific regulatory responses

Inappropriate use of scalpel removers; ransomware named as 2018's 'top hazard'; joint registry data; recent safety alerts

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under paragraph 61(2)(a)(iii) of the Act to release information from the Adverse Event Management System to the World Health Organization.

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

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