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Home » Topics » Regulatory

Regulatory
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Regulatory actions for Oct. 11, 2023

Oct. 11, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Intelivation Technologies.
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Regulatory actions for Oct. 11, 2023

Oct. 11, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annexon, Immpact, Inovio, Supernus.
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Canadian flag, microscope, AI illustration

Canada looks to Conscience for drug R&D

Oct. 10, 2023
By Mari Serebrov
Hoping to find a niche where it can be a pacesetter in biopharma development, the Canadian government is investing CA$49 million (US$36 million) in the new Conscience Open Science Drug Discovery Network. The investment will be used to accelerate drug R&D “by leveraging Canadian strengths in artificial intelligence and employing open science principles to drive efficiencies in building Canadian innovation capacity and delivering the medicines that Canadians need,” François-Philippe Champagne, minister of Innovation, Science and Industry, said in announcing the funding Oct. 5.
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Laptop displaying FDA logo
2023 Med Tech Conference

PCCP concept at risk of being subsumed in debate over artificial intelligence

Oct. 10, 2023
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.
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2023 Med Tech Conference

Advamed’s Whitaker more bullish on VALID Act in light of FDA draft rule for LDTs

Oct. 10, 2023
By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.


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Regulatory actions for Oct. 10, 2023

Oct. 10, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Karius, Neurasignal.
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Regulatory actions for Oct. 10, 2023

Oct. 10, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acousia, Alnylam, Aquestive, Canbridge, Jasper, Novartis, Okyo, Radiopharm, Tonix, Ultimovacs.
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2023 Med Tech Conference

Congress seen as having leeway to bring LDT user fees on board midstream in MDUFA VI

Oct. 9, 2023
By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.


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Inbrain graphene-based cortical brain interface

Inbrain granted breakthrough device designation for graphene-based neural platform

Oct. 9, 2023
By Shani Alexander

Inbrain Neuroelectronics SL was granted a breakthrough device designation from the U.S. FDA for its graphene-based neural platform as an adjunctive therapy for treating Parkinson’s disease. The platform, called intelligent network modulation system, harnesses the power of graphene and artificial intelligence to deliver highly focused, adaptive neuroelectronic therapy that re-balances pathological neural networks, easing the symptoms of Parkinson’s.


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Electric-field directed nerve regeneration
Patents

USC researchers develop technique for electric field directed optic nerve regeneration

Oct. 9, 2023
By Simon Kerton
The University of Southern California (USC) reported filing a patent for a retinal ganglion cell (RGC) stimulation system in which electrodes may be placed in, around or near sites of optic nerve injury to generate electric fields that can direct the direction of axonal regeneration.
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