studyfinds38m
Decoding ‘healthy’ on food labels: What does it really mean?
Discover the updated nutritional requirements for claiming a food as 'healthy' by the FDA. Learn how to navigate through ...
JD Supra1d
FDA’s Fresh Take on Use of “Healthy” in Food Labeling
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
By Sneha S K and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
JD Supra2d
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
MassDevice2d
Alleviant Medical wins FDA IDE, breakthrough nods for no-implant heart failure treatment
Alleviant Medical announced that it received FDA investigational device exemption and breakthrough device designation for its ...
RESTEM Receives FDA Fast Track Designation for Restem-L for Idiopathic Inflammatory Myopathy
L, a lead ULSC program, following the recent Orphan Drug Designation • Recently reported Phase 1 data of Restem-L demonstrated a clinically meaningful efficacy and significant reduction in steroid use ...
Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...
Food Safety News2d
FDA makes changes in food contact and lead in baby food as new year begins
The Food and Drug Administration will change its food safety policy as 2025 progresses.  Monday’s latest is the FDA issued a notice in the Federal ...
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar ...
FiercePharma3d
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
MassDevice3d
Integra Lifesciences receives FDA warning letter for quality systems issues at three locations
Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.