Guideline

FDA issues draft guidance for IVDs for emerging pathogens
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has released a draft guidance giving recommendations for validating in vitro diagnostic devices (IVDs) for emerging pathogens during a declared emergency.
January 8, 2025
Fda Sign Dc Social
USPSTF proposes new cervical cancer screening guidelines
By Liz Carey
While some signals abroad favor HPV DNA testing, USPSTF stays focused on cervical cytology alone or in combination.
December 11, 2024
Pathology Pap Smear Cervical
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FDA issues draft guidance for PCCPs for medical devices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The U.S. Food and Drug Administration (FDA) has issued a draft guidance document for its proposed policies for predetermined change control plans (PCCPs) for medical devices.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
Fda Sign Dc Social
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
Fda Button Social
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
Lab Vacutainer Test Tube Social
FDA issues draft guidance on diversity in clinical study enrollment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The U.S. Food and Drug Administration (FDA) has issued a draft guidance document intended to assist medical product sponsors with improving enrollment of clinical study participants through Diversity Action Plans.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
Amyloid Plaque Alzheimer Social
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
Fda Button Social
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
Regulation Wheel Social
Page 1 of 9
Next Page