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‘Significant Changes’ To Research Ethics Review Rules In Australia Include New Risk Model

 
• By Neena Brizmohun

Researchers, research offices and ethics committees are being encouraged to familiarize themselves with the new National Statement on Ethical Conduct in Human Research before it becomes applicable on 1 January 2024.

clinical trial
The majority of clinical trials in Australia must undergo an ethics committee assessment • Source: Shutterstock

Clinical trial sponsors in Australia are being advised to get up to speed with important changes made to the country’s rules and guidelines on the ethical conduct of research involving humans that will come into force soon.

The approach that will be used to assess the risk and benefit of research is completely different, law firm King & Wood Mallesons said of the revisions to the National Statement on Ethical Conduct in Human

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Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

More from Geography

23andMe Purchase Will Let Regeneron Scale Drug Development

 
• By Alaric DeArment

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Bringing Israeli Medical Device Candidates To The Right Partners In The US

 
• By Ashley Yeo

Despite regional unrest, it is business as usual for medtech innovators and investors in Israel as evidenced by continued high-value M&A of locally developed technologies. Irit Yaniv, co-chair of the medtech session at the upcoming BioMed Israel 2025, explained the unique dynamics of Israeli medtech innovation.