STAT6h
Leaving FDA, Califf is unapologetic — and warns of staff departures
In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...
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 limits toxic lead in baby food, but Illinois rep says more should be done
The Food and Drug Administration put guidelines in place to curb the amount of lead in baby food, but some like one Illinois ...
STAT6d
Save the Food and Drug Administration by breaking it up
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...
AccurKardia’s AK+ Guard gains FDA breakthrough device status
AccurKardia has gained the US Food and Drug Administration's (FDA) breakthrough device designation for its AI-powered ‘AK+ ...
Biden FDA moves forward with rule to lower nicotine in cigarettes, a ‘gift’ to cartels, critic says
Opponents argue that the change could cause current smokers to use more cigarettes to compensate for the lower nicotine ...
Afro2h
FDA updates the definition of ‘healthy’ foods
New FDA rules for 'healthy' food labels aim to align with federal dietary guidelines. Changes include limits on added sugars and sodium, and prioritize whole foods.
FDA sets limits on lead in some baby foods
But consumer advocates say the Food and Drug Administration's new guidance on lead limit in baby food doesn't go far enough.
aha.org18h
FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
JD Supra1d
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
COUR Pharmaceuticals Secures FDA Orphan Drug Designation for CNP-104 in Primary Biliary Cholangitis
COUR Pharmaceuticals, a clinical-stage biotechnology company developing first-in-class, disease-modifying therapies designed ...
FDA limits toxic lead in some baby foods
The Food and Drug Administration has set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and ...