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
Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this ...
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 ...
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 ...
OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
Time11d
Why Some Food Additives Banned in Europe Are Still on U.S. Shelves
(Daily Harvest did not provide comment for this story.) One reason companies may choose to label substances GRAS is that the FDA process to approve additives is relatively slow. So is its process ...
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 ...
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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
MedPage Today9h
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 ...
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 ...
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Former FDA head Gottlieb calls for less regulation of certain AI tools
Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st ...