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 ...
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 ...
Medpage Today on MSN1d
Most Clozapine Prescribers Satisfied With REMS Program
Among 196 doctors who prescribed clozapine, 64% said the positive aspects of the REMS certification process outweighed the ...
STAT8d
FDA clinical trial inclusivity guidelines will be back
Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...
Inquirer.net on MSN1d
FDA orders recall of antibiotics drug used vs pneumonia, bronchitis, UTI
The Food and Drug Administration (FDA) has ordered the recall of several batches of a brand of antibiotics used to treat ...
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 ...
Healio7d
Researchers stress need for clear, consistent standards in FDA review of psychiatric drugs
The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...
WGNO-TV New Orleans on MSN11d
Recall for broccoli sold at Walmart in 20 states upgraded to highest risk level: FDA
The Food and Drug Administration has upgraded its classification of a broccoli recall initially reported in late December, ...
Ozempic shown to reduce drinking in first trial in alcohol-use disorder
For years, people taking Ozempic or other drugs in the same class for diabetes and weight loss have noticed the medicines don ...
Cebu Daily News on MSN1d
FDA issues recall for ‘Triocef’ antibiotic due to quality defects
The Food and Drug Administration (FDA) has ordered the recall of several batches of Triocef oral drops (Cefixime), an antibiotic for bacterial infections like pneumonia, bronchitis, and UTI. In FDA ...
ClickOnDetroit10d
FDA upgrades recall for broccoli sold at Walmart in Michigan, 19 other states to highest risk level
The U.S. Food and Drug Administration has upgraded the recall for broccoli sold at Walmart stores in 20 states to its most ...
Federal News Network15d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.