Articles

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

Information to help sponsors understand the provisional approval pathway for prescription medicines.

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

s23 instruments supporting the new COR process have been updated.

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.

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