STAT4h
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 ...
The FDA Set Guidelines for 'Acceptable' Levels of Lead in Baby Food for the First Time — but Some Experts Say It's Not Enough
On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an ...
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 ...
Johnson & Johnson Gets FDA Fast-Track Designation for Posdinemab in Alzheimer's
The New Brunswick, N.J., pharmaceutical giant said posdinemab has shown potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated Alzheimer's patients, and in ...
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 ...
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 ...
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.
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 ...
JD Supra22h
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
Cheese Puffs Recall as FDA Issues Risk Warning
The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.
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 ...