Food and Drug Administration (FDA) news from FierceHealthcare
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Liquid Tamiflu shortage puts pressure on pharmacists, parents
Not a day goes by without some fear that the H1N1 vaccine will remain out of reach for too many, too long. Now, it's the children's dose of liquid Tamiflu that has parents scouring pharmacies,... Read more...
New IV flu drug approved for H1N1 use; First ED goes live on Calif. health info network;
> Peramivir, an intravenous flu drug, has been given emergency approval for some adults and children hospitalized with H1N1. The FDA granted the approval on Friday at the request of the CDC. This... Read more...
Radiation overdoses prompt class-action suit against Cedars-Sinai, GE Healthcare
Cedars-Sinai Medical Center and GE Healthcare have been named as defendants in a class-action suit representing patients who may have received radiation overdoses during CT brain perfusion scans at... Read more...
Some Calif. patients not told of radiation overdose
As we reported earlier this week, hundreds of patients at Cedars-Sinai Medical Center in Los Angeles received more than eight times the normal dose of radiation when getting diagnostic scans, a... Read more...
Hundreds of radiation overdoses went undetected for 18 months
It took 18 months before someone at Cedars-Sinai Medical Center in Los Angeles noticed that hundreds of patients had received more than eight times the normal dose of radiation. The error was... Read more...
FDA: Patients overexposed to radiation during perfusion CT imaging
The FDA has issued a warning suggesting that patients receiving perfusion CT imaging to help diagnose and treat stroke are getting far too big a dose of radiation. In fact, the agency found that over... Read more...
Study: Some physicians uninformed about approved uses of drugs
It's hard enough making sure the pharmaceutical companies don't find tricky ways to pitch physicians on off-label uses of their drugs. Apparently, that's not the only problem out there with off-label... Read more...
FDA vows better access to investigational drugs
By clarifying standards governing patient rules to "investigations" drugs, FDA leaders said the hope to help more people receive benefits from medicines that haven't yet been approved. Dr. Janet... Read more...
FDA device chief quits; Wireless home health exploding;
> The head of the FDA's devices devision is stepping down amid a cloud of questions--does this signal a tougher agency on the way? FiercePharma > Use of wireless home health technologies could... Read more...
Feds indict Synthes over off-label promotions
In recent years, orthopedic product maker Synthes Inc. chose a carefully-selected panel of surgeons and paid for them to attend training sessions on its new bone-mending cement. The cement, Norian... Read more...
