An adapter has been developed that will address the high DFT issue, but this has not yet been submitted for US FDA approval.
The US FDA today approved a new weight loss drug that will be called Qsymia, the brand name for the combination of two previously approved drugs, phentermine and extended-release topiramate.
Six months later the FDA sent us a form letter stating that they were still considering it, and that was the last we heard from them about it.
As a precautionary measure, on March 22, 2010, FDA recommended that US healthcare practitioners temporarily suspend the use of Rotarix.
The outbreak has been called one of the worst public health crises in the US in decades and the FDA has been under Congressional pressure to respond, especially after inspecting NECC in 2002 and issuing a warning letter in 2006, but failing to follow up with enforcement actions.
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The US Food and Drug Administration (FDA) has approved the "morning-after" pill without a prescription for women aged 15 and over.
Some samples exceeded the "provisional total tolerable intake" (PTTI) set by the US Food and Drug Administration (FDA) by a factor of 120.
Cephalon, the maker of Nuvigil, tried twice to get the drug officially approved to treat jet lag by the US Food and Drug Administration (FDA), the federal agency that regulates pharmaceutical companies.
In contrast, there is no such requirement for commercial hens in the US. Consequently, according to FDA data, there are about 142, 000 illnesses every year caused by consuming eggs contaminated by the most common strain of salmonella.
The US Food and Drug Administration (FDA) approved Levitra, an orange pill compared to Viagra's blue, based on studies showing that men were on average five times more likely to achieve an erection suitable for intercourse when taking the pill compared with those given a dummy medicine.
Rather, it is in line with a detailed investigation by the US Food and Drug and Administration (FDA).
In one case, for instance, an FDA chemist named Cheng Yi Liang was charged by the US Securities and Exchange Commission with insider trading on confidential info about upcoming announcements of 27 different FDA approval decisions involving 19 publicly traded companies.
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In light of the FDA warnings, a team of US researchers set out to explore this risk in a large and diverse clinical population.
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Indeed, the results are positive enough that one leading pain expert in the US argues the Food and Drug Administration (FDA) should only license abuse resistant painkillers.
Collins advocates that companies communicate important clinical information to CMS even before their devices have gotten to the market, but says that these discussions must not violate the confidentiality arrangements between device makers and the FDA. That sounds good to us.
Until the FDA approved the Genzyme plant, Fabry patients were clamoring for an alternative, given that Genzyme had instituted a controversial rationing program in the US. Many of these patients were hopeful the FDA would speed approval of the Shire biologic, since the progress surrounding the Genzyme plant was unclear.
The US food regulator, the Food and Drug Administration (FDA), has just declared that transgenic AquAdvantage salmon have "no significant impact", which is usually the last step before the final approval.
"Vanda provided the FDA with additional data and arguments that led us to reinterpret results of several of their studies, thus convincing the agency that there was sufficient data to support an approval action based on the existing clinical trials, " says Sandy Walsh, an FDA spokeswoman.
And the FDA is less likely to be concerned with adequate supplies for US patients now that Genzyme is gearing up production, even though full-blown availability is not expected until May or June.
Our best scientists and public health officials (FDA, EPA, state and local health departments) are once again quite serious about protecting us, and they have the expensive equipment to do so, measuring radiation in milk, water and food down to a single picocurie.
The FDA just concluded an advisory panel with experts representing various aspects of the testing community, which provided us with a set of opinions on several scientific issues in DTC testing.
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