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BioWorld - Wednesday, July 2, 2025
Home » Topics » Regulatory

Regulatory
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U.S. FDA headquarters

FDA wary of overreporting of clinical study protocol deviations

Dec. 31, 2024
By Mark McCarty
The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related compliance activities.
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Biontech’s $1.26B vaccine royalty settlement clears path forward

Dec. 30, 2024
By Mari Serebrov
Biontech SE agreed to pay up to nearly $1.26 billion in two separate settlements to resolve royalty disputes with the U.S. NIH and the University of Pennsylvania related to the COVID-19 vaccine the company partnered with Pfizer Inc.
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AI biotech research concept with lightbulb and digital background
Year in review

Regulatory developments for AI gained momentum in 2024

Dec. 30, 2024
By Mark McCarty
Artificial intelligence (AI) is no novelty for medical technology, but 2024 saw an interesting series of events in this area from across the globe. While some of these developments portend immediate regulatory clarity, some are harbingers of continued regulatory flux in 2025 and beyond.
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Magnifying glass atop paperwork

FDA recounts problems with CDS, but no denominator offered

Dec. 30, 2024
By Mark McCarty
The U.S. FDA has issued a second report in connection with device software functions, which includes surveillance data for clinical decision support (CDS) tools. While the report lists three events that qualify as adverse events, the FDA offered no information that would provide an adverse event rate for CDS products.
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Sequana Medical's Alfapump system

Sequana gets FDA nod for Alfapump to treat patients with ascites

Dec. 30, 2024
By Shani Alexander
Sequana Medical NV received premarket approval from the U.S. FDA for its Alfapump system to treat recurrent or refractory ascites due to liver cirrhosis. Data from the Poseidon pivotal study showed the implantable device, which removes ascites from the abdomen into the bladder, can eliminate the need for therapeutic paracentesis, improving the quality of life of patients.
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EU flags at European Commission building

New year, new five-year mandate, to make Europe more competitive

Dec. 30, 2024
By Nuala Moran
As 2025 gets underway, a new European Commission will start work on its new five-year mandate, with plans for multiple pieces of legislation that have implications for biotech and pharma – and the life sciences industry more broadly – due to be put forward.
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Gears with regulatory words
End of Year

2025 the year device makers need to rework quality management system

Dec. 27, 2024
By Mark McCarty
Device makers doing business in the U.S. have had a much more stable regulatory regime than has been true for companies in other jurisdictions, but that will shift somewhat in 2025. Brynn Stanley of Gardner Law told BioWorld that manufacturers should get busy with the U.S. FDA-mandated do-over of their quality management systems as the compliance deadline of February 2026 does not generally permit procrastination.
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Blood cells and bacteria
Year in review

Competition ticks up to reset the clock for sepsis

Dec. 27, 2024
By Annette Boyle
When every hour’s delay in treatment increases the risk of death 8%, dialing down time to diagnosis takes on acute urgency for clinicians and regulators. When the disease being treated kills 20% of the global population and 33% of hospitalized patients in the U.S., the market opportunity attracts investors. And when the technology makes breakthroughs possible that cut the time to targeted treatment from days to hours or even minutes, the number of products in development explodes, as the keen competition in sepsis diagnostics covered by BioWorld in 2024 demonstrates.
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Globe showing Asia-Pacific region
Year in review

AI drives financings, approvals for APAC med-tech in 2024

Dec. 27, 2024
By Marian (YoonJee) Chu
AI pulled in major financings and approvals for Asia med-techs in 2024 as Asia Pacific countries played to individual strengths to maximize AI’s applications in the health care sector. While breakaway AI technologies like OpenAI’s ChatGPT reshaped and boosted many industries, AI also drove major financings for APAC med-techs weathering a wider macroeconomic downturn, with AI-based companies accounting for five out of 11 IPOs tracked on BioWorld’s med-tech IPOs list.
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Year in review 2024 - US lawsuits

Year’s top US court cases to present new challenges for 2025

Dec. 24, 2024
By Mari Serebrov
As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025.
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