Guideline

ADLM releases guidance for blood lipid assessment, lipoprotein testing
By LabPulse.com staff writers
Document outlines recommendations for standardizing clinical lipid testing workflows.
September 4, 2024
Blood Test Samples Lab Social
Upcoming lung cancer molecular testing guidelines address 7 questions
By Liz Carey
Revised guideline addresses next-generation sequencing and expanded biomarker testing.
August 28, 2024
Lung Cancer Hotspot Social
FDA issues draft guidance for PCCPs for medical devices
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document for its proposed policies for predetermined change control plans (PCCPs) for medical devices.
August 23, 2024
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FDA releases final guidance on use of real-world data in regulatory submissions
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) released its final guidance on using real-world data in regulatory submissions, detailing how drug companies should assess data from electronic health records and medical claims to support their applications.
July 25, 2024
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FDA issues alert on BD vial supply shortage
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) is warning of a shortage of Becton Dickinson (BD) vials used to diagnose bacterial and fungal infections, suggesting that providers prioritize their use for patients with suspected bloodstream infections.
July 15, 2024
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FDA issues draft guidance on diversity in clinical study enrollment
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document intended to assist medical product sponsors with improving enrollment of clinical study participants through Diversity Action Plans.
June 27, 2024
Fda Sign Dc Social
WHO launches new guidance on TB diagnostics
By LabPulse.com staff writers
The World Health Organization has published updated guidance for the diagnosis of tuberculosis (TB), including new recommendations on the use of next-generation sequencing for the diagnosis of drug-resistant TB.
March 21, 2024
Bacteria Mycobacterium Tuberculosis Social
FDA updates draft guidance for Alzheimer's drug development biomarkers
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has released an updated draft guidance for the use of biomarkers aimed at sponsors and pharmaceutical companies developing drugs intended to treat early Alzheimer's disease.
March 14, 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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Labs and manufacturers face challenges with rollout of IVDR
By Matt Limb
Laboratories and medical device manufacturers have revealed how they face technical and workload challenges in gearing up to comply with stringent new European Union regulations.
October 2, 2023
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USP proposes synthetic alternative to horseshoe crab blood in endotoxin testing
By Nick Paul Taylor
The U.S. Pharmacopoeia (USP) has published draft guidelines on using a synthetic alternative to reagents derived from horseshoe crabs, advancing efforts to provide an alternative way of performing endotoxin testing.
August 31, 2023
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NGS working group provides recommendations for germline variant confirmation
By Elissa Wolfson
A joint report provides eight recommendations for standardizing orthogonal confirmation practices for germline variants detected by next-generation sequencing.
May 19, 2023
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