Business Insights
Diagnostic Technologies
Diseases
Point-of-Care Testing
Research & Development
Sign In
Policy & Regulation
Trends & Finance
Guideline
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 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
FDA issues draft guidance on diversity in clinical study enrollment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The U.S. Food and Drug Administration (FDA) has issued a draft guidance document intended to assist medical product sponsors with improving enrollment of clinical study participants through Diversity Action Plans.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
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
FDA updates draft guidance for Alzheimer's drug development biomarkers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The U.S. Food and Drug Administration (FDA) has released an updated draft guidance for the use of biomarkers aimed at sponsors and pharmaceutical companies developing drugs intended to treat early Alzheimer's disease.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
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
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
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
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
NCI study outlines challenges, opportunities in achieving Cancer Moonshot goals
By
Elissa Wolfson
A National Cancer Institute study outlined challenges and opportunities in achieving President Biden’s Cancer Moonshot goal -- a 50% reduction in U.S. cancer death rates by 2047.
April 18, 2023
Report identifies bias factors in clinical genetic testing
By
Nick Paul Taylor
ACMG committees worked together on a points-to-consider report in light of the potential for clinical, technical, and environmental biases to influence equitable access to clinical genetics testing.
April 14, 2023
AACC provides recommendations for detecting cervical cancer
By
LabPulse.com staff writers
The guidance aims to update healthcare and laboratory medicine professionals about the latest advancements in this field, and to help them select the most effective cervical cancer detection strategy for their patients, AACC said.
March 6, 2023
Page 1 of 9
Next Page