Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
A plan for the US Food and Drug Administration to propose banning formaldehyde and certain formaldehyde-releasing chemicals ...
JD Supra1d
From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
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FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes
The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and ...
STAT1d
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia
If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...
Trump is unlikely to end Medicare drug price talks — here's what that means for patients and pharma
Trump could either weaken the negotiations in a way that benefits the pharmaceutical industry, or try to achieve even deeper ...
NKGen Biotech Receives U.S. FDA Fast Track Designation for Troculeucel for the Treatment of Moderate Alzheimer’s Disease
The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s ...
The American Journal of Managed Care11d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
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Rare Diseases Are Neglected. The FDA Needs A Dedicated 'Center of Excellence for Rare Diseases'.
The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...
How Medicare Says It Arrives At ‘Fair’ Prescription Drug Prices
We now have a glimpse behind the curtain of how Medicare arrives at so-called maximum fair prices of prescription drugs it ...
JD Supra1d
A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...