Posts Tagged 'Food and Drug Administration'

FDA Drug Approvals Hit 18 Year High

In 2014, the FDA Center for Drug Evaluation and Research approved the most drugs since 1996. The FDA approved 41 novel medications last year, 62% more than the 27 approved in 2013. The only year that topped 2014 was 1996, when 53 new drugs were approved.

The new drug approvals consisted mostly of innovative, expensive treatments where competition is limited and costs of treatment can often exceed $100,000 per patient per year. Infectious disease drugs received ...

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FDA Launches Project to Check Pharmaceutical Quality

The United States Food and Drug Administration (FDA) has recently announced efforts to improve pharmaceutical quality and to establish an Office of Pharmaceutical Quality. A recent Reuters’ article looks at the FDA’s push to address lapses in quality control by pharmaceutical manufacturers, saying “the FDA has only had a general sense of the state of manufacturing quality at the country’s drugmakers.” According to the story, the FDA aims to have full quantitative information. The new Office ...

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Recently Approved Weight-Loss Drugs Will Not Be Covered by Many Insurers

The U.S. Food and Drug Administration (FDA) has approved a total of four prescription drugs for obesity since 2012. In a population where two-thirds of the adults are considered overweight or obese, it is not surprising that there is such a demand for the medications. The most recent drug to gain FDA approval is called Saxenda. The drug was approved in December, 2014, and insurance companies have already stated that they will not cover it.

A cautious ...

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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, the case ...

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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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