Posts Tagged 'Food and Drug Administration'

U.S. District Court Dismisses F.D.A. Whistleblower Suit

A recent decision by a U.S. District Court Judge dismissed a whistleblower lawsuit filed by six current and former scientists at the U.S. Food and Drug Administration (FDA). The employees had complained about the safety of various medical devices that came through the FDA. After doing so, they found that their private communications were being secretly monitored by FDA officials. The Washington Post reports that although the claim and its ramifications “troubled” the Judge, ...

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GSK Warned over Vaccine Plant

GlaxoSmithKline received a warning from the U.S. Food and Drug Administration about the conditions at its manufacturing facility in Quebec. The FDA said that the plant violated quality requirements during the manufacturing of its influenza vaccine Flulaval.

The FDA sent a letter to the company on June 12 after an inspection of the plant earlier this year. The investigation found that GSK had not established and followed written procedures to prevent microbiological contamination of the ...

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At-home dialysis helps quality of life

The East Montgomery County Observer tells the story of a 27-year-old man with kidney failure, whose quality of life was greatly improved when he began using a portable, in-home dialysis system.

He previously had to make a long drive and arrive at a dialysis center at 5 a.m. in order to finish the 4-hour treatment, then make it to work on time. Doctors told him that routine would be necessary three times ...

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Pattern still sought for deadly dialysis center infections

AL.com reports that a dialysis center in Bessemer, Alabama, remains shut down, but investigators have yet to identify a specific cause or pattern for the infections that killed two patients and hospitalized several others in May.

Although a laboratory analysis by the U.S. Centers for Disease Control and Prevention recovered six different bacteria from blood cultures of patients who were sickened, no pattern indicating a specific cause has been established.

The center’s owner, ...

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Experts: Dialysis not always best option for older patients

A federal law dating to the 1970s provides virtually free dialysis to anyone suffering from kidney failure, according to a story in the New York Times. But renal experts are trying to encourage doctors to give older kidney failure patients, many of whom suffer from other ailments, a more realistic assessment of how much the procedure is likely to help them.

According to the story, recent studies have concluded that not only ...

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Closed Fresenius dialysis center had history of problems

A dialysis center that was shut down in Bessemer, Alabama, following the infection-related deaths of two patients has a prior history of health violations, according to a report on Al.com.

In a report about a year ago, the Alabama health department cited the clinic over multiple infection-control deficiencies. In one of those cases, a patient was hospitalized.

The clinic’s owner, German company Fresenius, has previously been accused of subjecting patients to read more.... --> continue reading...

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