Advances in technology mean it’s now possible to 3D print everything from prosthetic limbs to skin, bones and organs.
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.
There is currently a weak process of checking claims made in advertisements for medicines, to ensure they don't mislead or deceive consumers -this could be abandoned if a bill passes parliament.
Australia’s medical regulator needs to do more about cybersecurity.
Australia's Therapeutic Goods Administration must learn to deal with software rather than simply bits of metal and plastic.
Embedded medical devices will continue to be vulnerable to cybersecurity threats. The pacemaker depicted is not made by Abbott’s.
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.
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.
Hundreds of women have complained of adverse reactions from transvaginal mesh implants.
Regulatory bodies approved some medical devices to treat pelvic organ prolapse and urinary incontinence before having data to prove their safety and efficacy.
Weaker regulatory standards in the US can impact health everywhere.
Intuitively, it might seem desirable to speed up access to medicines. But this means more drugs will be approved that may subsequently prove unsafe or ineffective.
How do you really know if vitamin and mineral supplements really ‘help your heart’ or ‘boost your mood’?
If the Therapeutic Goods Administration implements new proposals to regulate complementary medicines, you can be more confident they actually do what they say on the packet.
The effective ban on e-cigarettes in Australia forces people to access unregulated nicotine products to help them quit smoking.
The recent decision to effectively ban e-cigarettes will hurt poor and disadvantaged smokers the most.
E-cigarettes remain effectively banned in Australia because advocates' evidence has failed to convince the Therapeutic Goods Administration.
Advertisements for complementary medicines don’t always reflect what’s in the bottle.
Consumers can't always be confident claims for complementary medicines stack up. Here's how to foster truth in advertising.
Classifying e-cigarettes as a nicotine replacement therapy could help the tobacco industry influence health policy.
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.
Rare cancers are those where the incidence is less than six cases per 100,000 people.
Should new understandings of how cancers develop and could be targeted mean we should change the way the scheme registers cancer drugs?
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
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.
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
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.
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.
Overseas drug approval may have unintended consequences.
One of the much-heralded platforms of the Abbott government is its promise to business to reduce red tape and burdensome regulatory obligations. Pharmaceuticals are a multi-billion dollar global industry…
This product is being sold despite being removed from the Australian Register of Therapeutic Goods by the TGA.
I submitted a complaint about the promotion of “FatBlaster Reducta” (ARTG no: 176366) to the Therapeutic Goods Administration in March 2011. The product is a “complementary medicine” containing an extract…