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.
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.
While PPS is approved in oral capsule form to treat bladder inflammation, it is not yet approved as in injection for knee and bone problems. But AFL players have been given special access.
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 Therapeutic Goods Administration must learn to deal with software rather than simply bits of metal and plastic.
Pacemakers are Internet of Things devices for the human body, but they're still not particularly secure.
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.
Regulatory bodies approved some medical devices to treat pelvic organ prolapse and urinary incontinence before having data to prove their safety and efficacy.
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.
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 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.
Consumers can't always be confident claims for complementary medicines stack up. Here's how to foster truth in advertising.
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.
Should new understandings of how cancers develop and could be targeted mean we should change the way the scheme registers cancer drugs?
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.
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.
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.
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.