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Home » Topics » Regulatory

Regulatory
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Purple-tinted test tubes and dropper

South Korea ups 2025 health agency budget, biomedical R&D funds

Jan. 6, 2025
By Marian (YoonJee) Chu
South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% increase in funding to research and develop innovative biotechnologies.
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Pill in immersive interface

US FDA issues first AI guidance for drug development

Jan. 6, 2025
By Mari Serebrov
With artificial intelligence (AI) becoming more and more common in drug development since 2016, the U.S. FDA is now issuing its first draft guidance on that use. The “FDA recognizes the increased use of AI throughout the drug product life cycle and across a range of therapeutic areas. In fact, CDER has seen a significant increase in the number of drug application submissions using AI components over the past few years,” a CDER spokesperson told BioWorld. “These submissions traverse the drug product life cycle, which includes nonclinical, clinical, postmarketing and manufacturing phases.”
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Transmission electron micrograph of HIV particles

As STIs explode, at-home testing reduces diagnostic barriers

Jan. 6, 2025
By Annette Boyle
For more than a decade, HIV remained the only sexually transmitted infection (STI) with U.S. FDA approval of at-home sample collection, but a growing number of tests for sexually transmitted infections have received the regulatory greenlight for patients to swab themselves in the privacy of their own homes in recent years. With STIs reaching levels not seen in decades, regulators and physicians hope that the move will increase diagnostic rates and reduce disease spread by overcoming stigma and access barriers.
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Cyber security padlock

HHS floats much more stringent set of HIPAA security measures

Jan. 6, 2025
By Mark McCarty
Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The Department of Health and Human Services released a draft update for HIPAA cybersecurity mandates – the final version of which is sure to be accompanied by much more vigorous enforcement.
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AI biotech research concept with lightbulb and digital background

FDA inks draft guidance for AI applicable across product centers

Jan. 6, 2025
By Mark McCarty
Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both premarket submissions and life cycle management considerations, the more important consideration is that the FDA’s centers for devices, drugs and biologics have all signed off on the draft, suggesting an agency-wide convergence in thinking about AI.
Read More
U.K. flag on stethoscope

UK legislation seeks to revamp clinical trial regulations

Jan. 3, 2025
By Nuala Moran
The U.K. is embarking on the biggest overhaul of clinical trials regulations in 20 years in a bid to retake ground that was lost following Brexit, when the Medicines and Healthcare products Agency was excised from the EMA’s regulatory system.
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U.S. Capitol building

New Year rings in a new US Congress

Jan. 3, 2025
By Mari Serebrov
It was in with the new and out with the old Jan. 3 as the gavel came down on the first session of the 119th U.S. Congress. Although Republicans will control both the House and Senate for the next two years, their narrow majority could prove a challenge to passing some of President-elect Donald Trump’s agenda, including his proposal to cut the corporate tax rate to 15% for companies that manufacture their products in the U.S.
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Hourglass on glowing circuit board, symbolizing time and technology
Year in review

EU’s med-tech regulatory struggles continue into 2025

Jan. 3, 2025
By Mark McCarty
Regulatory overhauls are never a simple affair, but the med tech industry ran into an amorphous, ennui-inducing mess in dealing with the EU Medical Device Regulation almost immediately. Even though the underlying legislation passed in 2017, the MDR impasse continued to impede innovation on the continent – a problem that might be only partly resolved in 2025.
Read More
Globe showing Asia-Pacific region

Strong growth predicted for APAC med-tech market in 2025

Jan. 2, 2025
By Tamra Sami
The Asia Pacific med-tech market is projected to reach $140 billion in 2025 in value, growing roughly 5% per year, driven largely by a rising demand for advanced and personalized medical technologies, including telemedicine and precision medicine.
Read More
Medicare puzzle
Year in review

Medicare coverage issues abound in 2024

Jan. 2, 2025
By Mark McCarty
The device industry is extraordinarily dependent on administrative activity where Medicare coverage is concerned, and this was exceptionally evident in 2024 when software and digital health coverage policies remained bogged down.
Read More
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