Articles on Therapeutic Goods Administration

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The effectiveness of a drug may be evaluated based on its potential to shrink tumours – but this doesn’t necessarily equate to improved survival rates. From shutterstock.com

Do new cancer drugs work? Too often we don’t really know (and neither does your doctor)

National drug regulators use evidence from clinical trials to decide whether new cancer drugs will be approved for use. But these studies are often flawed.
It’s not just women who are the losers following the latest TGA announcement. People with all types of medical devices need better regulatory protection. from www.shutterstock.com

The TGA’s proposed breast implant ban exposes a litany of failures, and fails to protect women

The proposed Australian ban of some types of breast implants is too little, too late. It also reveals regulatory failures that need to be fixed if Australian consumers are to be protected.
Advances in technology mean it’s now possible to 3D print everything from prosthetic limbs to skin, bones and organs. armymedicine/flickr

Proposed new regulations for 3D printed medical devices must go further

Who should be legally responsible when 3D printed devices fail? Proposed changes to the Therapeutic Goods Administration's regulatory framework have the potential to settle that question.
Embedded medical devices will continue to be vulnerable to cybersecurity threats. The pacemaker depicted is not made by Abbott’s. REUTERS/Fabrizio Bensch

Three reasons why pacemakers are vulnerable to hacking

Pacemakers are Internet of Things devices for the human body, but they're still not particularly secure.
The Australian drugs regulator is overhauling the health claims made by suppliers of complementary medicines, including homeopathic therapies. And some curious options are up for discussion. from www.shutterstock.com

New complementary medicine health claims lack evidence, so why are they even on the table?

Would you trust a complementary medicine described as "vermifuge", "vulnerary" or "emmenagogue"? That's what new labelling proposes and not everyone's happy about it.
Classifying e-cigarettes as a nicotine replacement therapy could help the tobacco industry influence health policy. from www.shutterstock.com

How e-cigarettes could ‘health wash’ the tobacco industry

Classing e-cigarettes as quit smoking aids could help rebrand the tobacco industry as a legitimate player in health policy. Here's why we should be concerned.
Representatives of the 12 Trans-Pacific Partnership (TPP) member countries at a press conference in Atlanta, after a deal was reached. EPA/Erik S. Lesser

Why biologics were such a big deal in the Trans Pacific Partnership

Before the last round of negotiations, only a handful of issues remained in the way of concluding the TPP. A potential deal-breaker for Australia was intellectual property protections for biologics.
Off-label use is when an approved medicine is prescribed for a different reason, at a different dose, or in different patient groups than originally intended. Benny Lin/Flickr

Explainer: why are off-label medicines prescribed?

The off-label use of medicines is not illegal and it doesn't mean regulators have specifically "disapproved" its use. But there are a number of issues to consider before using a medicine off-label.
Trade minister Andrew Robb attends negotiations for the Trans Pacific Partnership in Sydney last year. Dan Himbrechts/AAP Image

How the battle over biologics helped stall the Trans Pacific Partnership

Over the next few weeks, the trade minister will be under intense pressure to renege on the government’s commitment to reject anything in the Trans Pacific Partnership that could undermine the PBS.
Despite assurances from Minister for Trade and Investment Andrew Robb, the TPP could negatively affect Australian health policy. Dan Himbrechts/AAP

Leaked TPP investment chapter shows risks to Australia’s health

The latest part of the TPP to be leaked is its investment chapter. And like almost everything we know about the secretive negotiations for the agreement, it provides plenty of cause for concern.

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