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Home » Topics » Regulatory

Regulatory
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Alpha-Stim AID device

Alpha-Stim AID finally offered to patients in the UK with anxiety

July 7, 2023
By Shani Alexander
Electromedical Products International Inc. (EPI) Alpha-Stim AID technology is finally being made available by the NHS in the U.K. to treat patients with anxiety some two years after the National Institute for Health and Care Excellence (NICE) said there was not enough good-quality evidence to support the case for routine adoption.
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Regulatory actions for July 7, 2023

July 7, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Candela, Magstim.
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Regulatory actions for July 7, 2023

July 7, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Astellas, Curis, Kazia, Kyverna, Merus, Novavax, OSE, Sihuan.
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Leqembi

Biogen, Eisai FDA win with Leqembi ‘a big deal’ in AD space; CMS on board, too

July 7, 2023
By Randy Osborne
The black box warning appended to the label of Alzheimer’s disease (AD) drug Leqembi (lecanemab) took some on Wall Street mildly aback but failed to surprise others, as analysts mulled what the full approval, granted July 6 by the U.S. FDA, might mean for other developers in the space.
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State drug pricing law sparks US constitutional challenge

July 6, 2023
By Mari Serebrov
The Association for Accessible Medicines fired off a constitutional challenge in U.S. federal court July 5 to provisions included in Minnesota’s new budget law that would restrict price increases for generic and off-patent drugs.
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Regulatory actions for July 6, 2023

July 6, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bellaseno, Biotronik, Genesis Medtech, Inovedis, Livsmed, Medrhythms.
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Renalytix receives de novo authorization

July 6, 2023
By Annette Boyle
The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
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Document illustration

Stakeholders seek clarity on intended use, combo products in FDA’s change control draft

July 6, 2023
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.
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Regulatory actions for July 6, 2023

July 6, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Amneal, Ayala, Biocardia, C4, Clarity, Impact, Incyte, Infant, Jacobio, Moderna, Poseida, Rarestone, Taiho, Tiumbio, Vertex.
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With MFDS expanded approval, Yuhan's Leclaza moving to first-line NSCLC treatment

July 5, 2023
By Marian (YoonJee) Chu
South Korean pharmaceutical giant Yuhan Corp. gained Korea’s MFDS approval to expand indications for its potent oral third-generation tyrosine kinase inhibitor Leclaza (lazertinib) as a first-line treatment for EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC).
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