Policy and Regulation: Page 9

T2 Biosystems gets FDA nod to expand bacteria panel
By LabPulse.com staff writers
T2 Biosystems announced it received 510(k) clearance to add A. baumannii to its T2Bacteria Panel.
February 12, 2024
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Why many high-risk IVDs are being reclassified
By LabPulse.com staff writers
The FDA announced that its Center for Devices and Radiological Health (CDRH) will reclassify most in vitro diagnostics (IVDs) that are in the high-risk category to moderate risk to allow their manufacturers an easier path to FDA clearance.
February 1, 2024
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FDA orders new info warnings on CAR-T therapies
By LabPulse.com staff writers
Following its review of reports of T-cell malignancies associated with the administration of six CAR-T immunotherapies, the FDA has instructed the manufacturers to include warnings in the prescribing info for the therapeutics.
January 30, 2024
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FDA accepts 1st AI-based tool into Istand pilot program
By LabPulse.com staff writers
A mental health assessment tool has become the first AI-powered tool to be accepted into the U.S. Food and Drug Administration's (FDA) Innovative Science and Technology Approaches for New Drugs (Istand) pilot program for advancing drug development.
January 26, 2024
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New bills sound alarms on foreign adversaries and medical diagnostics
By LabPulse.com staff writers
Legislators wary of certain foreign biotech companies have introduced bipartisan, bicameral legislation that would ban federal contracts and funding mechanisms to companies with ties to foreign adversaries.
January 26, 2024
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Precision medicine at tipping point with looming FDA LDT oversight
By Liz Carey
FDA targets companion diagnostics (CDx) LDTs first. In addition, CAP and AdvaMedDx set clear expectations, and what to know about the FDA-CMS joint statement on FDA oversight.
January 25, 2024
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Sensorion receives clinical trial approval for congenital deafness gene therapy
By LabPulse.com staff writers
French biotech firm Sensorion has received approval to initiate a phase I and II clinical trial in France of SENS-501 (the OTOF-GT program), its gene therapy for gene-mediated hearing impairment.
January 22, 2024
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Imvaria gets FDA marketing authorization for Fibresolve
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Imvaria for the use of Fibresolve.
January 16, 2024
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NowDiagnostics submits FDA de novo request for OTC syphilis test
By LabPulse.com staff writers
NowDiagnostics has submitted a de novo authorization request to the U.S. Food and Drug Administration (FDA) for its First to Know over-the-counter (OTC) syphilis test.
January 10, 2024
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Health Canada approves Pfizer’s hemophilia gene therapy
By LabPulse.com staff writers
Health Canada, Canada’s regulatory agency, has approved Pfizer's Beqvez (fidanacogene elaparvovec) as a gene therapy treatment for adults with moderately severe to severe hemophilia B.
January 3, 2024
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CMS final rule settles controversial proposal
By Liz Carey
A year-end final rule from the Centers for Medicare and Medicaid Services (CMS) settled a contentious proposal to include nursing degrees in the qualifications for high-complexity testing personnel under CLIA of 1988 regulations.
January 4, 2024
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Regulators to examine Thermo Fisher acquisition of Olink
By LabPulse.com staff writers
Shares of proteomics firm Olink dropped approximately 3% last week following the disclosure by the company that the U.K.’s regulatory body will investigate its pending acquisition by Thermo Fisher.
December 27, 2023
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