All Regulatory Rapporteur articles in RegRepPlus 2024 – Page 2
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Industry newsNon-surgical gastric balloon to be made available on NHS
A novel gastric ‘balloon’ medical device has been made available on the UK’s National Health Service (NHS) for the first time.
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Industry newsMHRA tightens restrictions on fluoroquinolones
The UK’s MHRA has announced that fluoroquinolone antibiotics can only be prescribed when no other antibiotic is appropriate.
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Industry newsDevice which can detect skin cancer approved by FDA
The FDA has approved a wireless hand-held device that uses an artificial intelligence-powered algorithm to detect skin cancer.
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Industry newsScientists hail gram-negative-bacteria killing antibiotic
A novel class of antibiotic has been discovered that is effective against the extensive drug-resistant, gram-negative bacteria, Crab.
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Industry newsMHRA workplan to support safe access to medtech
The MHRA has published a two-year workplan which will see the introduction of a range of new regulations for medical devices in the UK.
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Industry newsEMA set to host psychedelics uses workshop in April
The EMA will host a workshop to discuss the therapeutic potential of psychedelic substances to address unmet medical need.
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Industry news3D-printed device could reduce need for animal testing
A 3D-printed device is able to determine the effects of drugs on the human body and could help reduce the need for testing drugs in animals.
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Industry newsNon-hormonal menopause drug approved in UK
The MHRA has authorised a non-hormonal medicine, Veoza, which targets a protein in the brain to stop vasomotor symptoms in menopause.
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Industry newsEMA/HMA publish workplan for the responsible use of AI
The EMA and the HMA have published a multi-annual AI workplan 2023-2028 to facilitate the safe and effective use of artificial intelligence.
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Industry newsMHRA’s IRP pathway now open for new medicines approvals
Medicines manufacturers can now submit marketing authorisation applications via the MHRA’s International Recognition Procedure.
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